GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Ebola Clinical Trial

Official title:
PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT02818582
Other study ID #	999916137
Secondary ID	16-I-N137
Status	Completed
Phase	Phase 2
First received
Last updated
Start date	July 1, 2016
Est. completion date	August 31, 2020

Study information
Verified date	October 2019
Source	National Institutes of Health Clinical Center (CC)
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen. Objective: To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans. Eligibility: Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen Design: Participants will be screened with: Questions Physical exam Eye exam Blood tests 2 semen samples if they have not had it tested recently Participants must live near the study site in Liberia for 6 months. Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour. Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4. After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample. Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam. When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.

Description:

With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented. There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit. This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak. Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.

Recruitment information / eligibility
Status	Completed
Enrollment	38
Est. completion date	August 31, 2020
Est. primary completion date	August 31, 2020
Accepts healthy volunteers	No
Gender	Male
Age group	18 Years to 99 Years
Eligibility	- INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: - Men more than or equal to 18 years of age. - One of two semen samples with Ebola virus RNA detection (defined as a positive PCR for NP or GP using the GeneXpert assay within 42 days prior to randomization). - Willingness to be available for study evaluations for 6 months. - Willingness to allow storage of biological samples. - Willingness to be followed by a Participant Tracker. - Willingness to refrain from alcohol consumption for study days -7 to 14. - Willingness to comply with MOH & CDC guidance on using a condom for sexual activity and at least through week 24 of the study. EXCLUSION CRITERIA: Individuals meeting any of the following criteria will be excluded from study participation: - Estimated glomerular filtration rate less than 60 mL/min/1.73m^2 - History of significant renal disease - History of significant liver disease - Evidence of liver disease on physical exam such as ascites - Aspartate transaminase (AST) or alanine transaminase (ALT), greater than the upper limit of normal, a prothrombin time 1.1 times greater than the upper limits of normal, normal, or a total bilirubin > 1.5 times the upper limits of normal(per Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity tables version 2.0 Nov. 2014). - Presence of Grade 2 or higher abnormalities for: low hemoglobin, low white blood count (WBC), low platelets, or low or high potassium (per DAIDS toxicity tables version 2.0 Nov. 2014). - Presence of greater than Grade 2 abnormalities for low or high sodium (per DAIDS toxicity tables version 2.0 Nov. 2014). - Any condition that, in the opinion of the investigator, would compromise the safety of the study subject or staff, or would prevent proper conduct of the study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GS-5734
Daily GS-5734 delivered intravenously (IV) for 5 days

Other:
• Placebo Comparator
Placebo delivered intravenously (IV) for 5 days.

Locations
Country	Name	City	State
Guinea	Partnership of Clinical Research in Guinea (PREGUI) / Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah	Forécariah	Maferinyah
Liberia	JFK Hospital Partnership for Research for Vaccines and Infectious Diseases in Liberia (PREVAIL)	Monrovia

Sponsors *(2)*
Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Gilead Sciences

Countries where clinical trial is conducted

Guinea, Liberia,

References & Publications (3)

Bwaka MA, Bonnet MJ, Calain P, Colebunders R, De Roo A, Guimard Y, Katwiki KR, Kibadi K, Kipasa MA, Kuvula KJ, Mapanda BB, Massamba M, Mupapa KD, Muyembe-Tamfum JJ, Ndaberey E, Peters CJ, Rollin PE, Van den Enden E, Van den Enden E. Ebola hemorrhagic fever in Kikwit, Democratic Republic of the Congo: clinical observations in 103 patients. J Infect Dis. 1999 Feb;179 Suppl 1:S1-7. — View Citation

de Vries DH, Rwemisisi JT, Musinguzi LK, Benoni TE, Muhangi D, de Groot M, Kaawa-Mafigiri D, Pool R. The first mile: community experience of outbreak control during an Ebola outbreak in Luwero District, Uganda. BMC Public Health. 2016 Feb 16;16:161. doi: 10.1186/s12889-016-2852-0. — View Citation

Feldmann H, Geisbert TW. Ebola haemorrhagic fever. Lancet. 2011 Mar 5;377(9768):849-62. doi: 10.1016/S0140-6736(10)60667-8. Review. — View Citation

Outcome
Type	Measure	Description	Time frame
Primary	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.	Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)
Primary	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.	Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Secondary	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase	Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.	Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)
Secondary	Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase	Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.	Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 1	Treatment phase - Day 1
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 2	Treatment phase - Day 2
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 3	Treatment phase - Day 3
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 4	Treatment phase - Day 4
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 5	Treatment phase - Day 5
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 8	Treatment phase - Day 8
Secondary	Mean Change From Baseline in ALT Value at Day 11	Mean change from baseline in alanine transaminase (ALT) value at day 11	Treatment phase - Day 11
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at day 16	Treatment phase - Day 16
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at at day 24	Treatment phase - Day 24
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at at day 28	Treatment phase - Day 28
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at week 8	Follow-up phase - Week 8
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) Value at week 12	Follow-up phase - Week 12
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at week 16	Follow-up phase - Week 16
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at week 20	Follow-up phase - Week 20
Secondary	Mean Change From Baseline in ALT Value	Mean change from baseline in alanine transaminase (ALT) value at week 24	Follow-up phase - Week 24
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1	Treatment phase - Day 1
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2	Treatment phase - Day 2
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3	Treatment phase - Day 3
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4	Treatment phase - Day 4
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5	Treatment phase - Day 5
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8	Treatment phase - Day 8
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11	Treatment phase - Day 11
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16	Treatment phase - Day 16
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24	Treatment phase - Day 24
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28	Treatment phase - Day 28
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8	Follow-up phase - Week 8
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12	Follow-up phase - Week 12
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16	Follow-up phase - Week 16
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20	Follow-up phase - Week 20
Secondary	Mean Change From Baseline in aPTT Value	Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24	Follow-up phase - Week 24
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) Value at day 1	Treatment phase - Day 1
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) Value at day 2	Treatment phase - Day 2
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 3	Treatment phase - Day 3
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 4	Treatment phase - Day 4
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 5	Treatment phase - Day 5
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 8	Treatment phase - Day 8
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 11	Treatment phase - Day 11
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 16	Treatment phase - Day 16
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 24	Treatment phase - Day 24
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at day 28	Treatment phase - Day 28
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at week 8	Follow-up phase - Week 8
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12	Follow-up phase - Week 12
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16	Follow-up phase - Week 16
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20	Follow-up phase - Week 20
Secondary	Mean Change From Baseline in AST Value	Mean change from baseline in aspartate transaminase (AST) value at week 24	Follow-up phase - Week 24
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 1	Treatment phase - Day 1
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 2	Treatment phase - Day 2
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 3	Treatment phase - Day 3
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 4	Treatment phase - Day 4
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 5	Treatment phase - Day 5
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 8	Treatment phase - Day 8
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 11	Treatment phase - Day 11
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 16	Treatment phase - Day 16
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 24	Treatment phase - Day 24
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at day 28	Treatment phase - Day 28
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at week 8	Follow-up phase - Week 8
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at week 12	Follow-up phase - Week 12
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at week 16	Follow-up phase - Week 16
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at week 20	Follow-up phase - Week 20
Secondary	Mean Change From Baseline in INR Value	Mean change from baseline in international normalized ratio (INR) value at week 24	Follow-up phase - Week 24
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 1	Treatment phase - Day 1
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 2	Treatment phase - Day 2
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 3	Treatment phase - Day 3
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 4	Treatment phase - Day 4
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 5	Treatment phase - Day 5
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 8	Treatment phase - Day 8
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 11	Treatment phase - Day 11
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 16	Treatment phase - Day 16
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 24	Treatment phase - Day 24
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at day 28	Treatment phase - Day 28
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at week 8	Follow-up phase - Week 8
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at week 12	Follow-up phase - Week 12
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at week 16	Follow-up phase - Week 16
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at week 20	Follow-up phase - Week 20
Secondary	Mean Change From Baseline in PT Value	Mean change from baseline in prothrombin time (PT) value at week 24	Follow-up phase - Week 24
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) [DAIDS AE grading table] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 1
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 2
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 3
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 4
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 5
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 8
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 11
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 16
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 24
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 28
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 8
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 12
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 16
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 20
Secondary	Number of Participants With Increase in Grade From Baseline for ALT Value	Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 24
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 1
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 2
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 3
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 4
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 5
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 8
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 11
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 16
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 24
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 28
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 8
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 12
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 16
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 20
Secondary	Number of Participants With Increase in Grade From Baseline for aPTT Value	Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 24
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 1
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 2
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 3
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 4
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 5
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 8
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 11
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 16
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 24
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Treatment phase - Day 28
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 8
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 12
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 16
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 20
Secondary	Number of Participants With Increase in Grade From Baseline for AST Value	Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)	Follow-up phase - Week 24
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 1
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 2
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 3
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 4
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 5
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 8
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 11
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 16
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 24
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Treatment phase - Day 28
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 8
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 12
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 16
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 20
Secondary	Number of Participants With Increase in Grade From Baseline for PT Value	Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)	Follow-up phase - Week 24
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20	Follow-up phase - Week 20
Secondary	Participants With Grade 1 ALT Level	Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 1 AST Level	Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28	Follow-up phase - Week 28
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20	Follow-up phase - Week 20
Secondary	Participants With Grade 2 ALT Level	Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 2 AST Level	Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28	Follow-up phase - Week 28
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20	Follow-up phase - Week 20
Secondary	Participants With Grade 3 ALT Level	Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 3 AST Level	Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28	Follow-up phase - Week 28
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine aminotransferase (ALT) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 20	Follow-up phase - Week 20
Secondary	Participants With Grade 4 ALT Level	Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 1	Treatment phase - Day 1
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 2	Treatment phase - Day 2
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 3	Treatment phase - Day 3
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 4	Treatment phase - Day 4
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 5	Treatment phase - Day 5
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 8	Treatment phase - Day 8
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 11	Treatment phase - Day 11
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 16	Treatment phase - Day 16
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 24	Treatment phase - Day 24
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 28	Treatment phase - Day 28
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 8	Follow-up phase - Week 8
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 12	Follow-up phase - Week 12
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 16	Follow-up phase - Week 16
Secondary	Participants With Grade 4 AST Level	Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 24	Follow-up phase - Week 24
Secondary	Participants With Grade 4 AST Level	Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 28	Follow-up phase - Week 28

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05284097` - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study	Phase 2
Completed	`NCT02240875` - A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo	Phase 1
Completed	`NCT05064956` - Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)	Phase 2
Completed	`NCT05079750` - A Study of a New Vaccine Against Two Types of Ebola	Phase 1
Completed	`NCT04385719` - Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy	Phase 2
Active, not recruiting	`NCT05301504` - A Study in Tanzania of a New Vaccine Against Two Types of Ebola	Phase 1
Completed	`NCT00646152` - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study	Phase 1
Completed	`NCT02370589` - Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects	Phase 1
Completed	`NCT04228783` - A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants	Phase 3
Active, not recruiting	`NCT03031912` - African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola	Phase 2

GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Countries where clinical trial is conducted

References & Publications (3)

Outcome