Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

HIV Infections Clinical Trial

Official title:

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01854775
• Other study ID #: GS-US-292-0106
• Secondary ID: 2013-002780-26
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: May 6, 2013
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents.

The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B).

The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: December 2024
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Key Inclusion Criteria:

• Cohort 1

• 12 years to < 18 years of age at baseline

• Weight greater than or equal to 35 kg (77 lbs)

• Plasma HIV-1 ribonucleic acid (RNA) levels of = 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)

• Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)

• No prior use of any approved or experimental anti-HIV-1 drug for any length of time

• Cohort 2

• 6 years to < 12 years of age at baseline

• Weight greater than or equal to 25 kg (55 lbs)

• Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for = 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.

• Cohort 3

• Age at baseline: = 2 years old

• Weight at screening: = 14 kg (31 lbs) to < 25 kg (55 lbs)

• Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for = 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Key Exclusion Criteria:

• Hepatitis B or hepatitis C virus infection

• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.

• Individuals experiencing decompensated cirrhosis

• Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome (AIDS)
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• E/C/F/TAF
Tablets administered orally with food.
• E/C/F/TAF (Low Dose)
90/90/120/6 mg STR administered once daily orally with food.

Locations

Country	Name	City	State
South Africa	Be Part Yoluntu Centre	Cape Town
South Africa	Desmond Tutu HIV Foundation	Cape Town
South Africa	KIDCRU Ward J8	Cape Town
South Africa	Clinical HIV Research Unit	Johannesburg
South Africa	Empilweni Services and Research Unit (ESRU)	Johannesburg
South Africa	Perinatal HIV Research Unit Baragwanath Hospital	Johannesburg
Thailand	The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)	Bangkok
Thailand	Queen Savang Vadhana Memorial Hospital	Chon Buri
Thailand	Department of Pediatrics, Faculty of Medicine, Khon Kaen University	Khon Kaen
Uganda	Joint Clinical Research Centre	Kampala
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Miller's Children Hospital	Long Beach	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's Research Institute	Washington	District of Columbia
Zimbabwe	University of Zimbabwe - Clinical Research Centre	Belgravia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Zimbabwe,  South Africa,  Thailand,  Uganda, 

References & Publications (14)

Gaur A, Kizito H, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, et al. Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Treatment-Naive Adolescents [Poster 817]. Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25;

Gaur A, Natukunda E, Kosalarksa P, Batra J, Rakhmanina N, Coluci A, et al. Pharmacokinetics, Safety, and Efficacy of E/C/F/TAF in HIV-1-Infected Children (6 to <12 years) [Poster 424]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 F

Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N, Rassool M, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, Porter D, Shao Y, Myers M, Ting L, SenGupta D, Quirk E, Rhee MS. Safety, efficacy, and pharmacokinetics of a single-tablet regimen containin — View Citation

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, et al. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) [Presentation #MOAB0104]. International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention; 2015 19-22 July; Vancouver, Canada.

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Pos

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Pos

Liberty A, Strehlau R, Rakhmanina N, Chokephaibulkit K, Koziara J, Kaur H, et al. Acceptability and palatability of low dose B/F/TAF and E/C/F/TAF in children (= 2y) with HIV. (Abstract 57) International Workshop on HIV Pediatrics 2020; 16-17 November 202

Natukunda E, Gaur AH, Kosalaraksa P, Batra J, Rakhmanina N, Porter D, Shao Y, Zhang H, Pikora C, Rhee MS. Safety, efficacy, and pharmacokinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppresse — View Citation

Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim J, Kaur H, et al. Safety, pharmacokinetics, and efficacy of low dose E/C/F/TAF in virologically suppressed children = 2 years old living with HIV. (Abstract 3) International Workshop on HIV Pediatrics

Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim JG, Kaur H, et al. Safety, pharmacokinetics and efficacy of low dose E/C/F/TAF in virologically suppressed children = 2 years old living with HIV. (Abstract OABLB0101) 23rd International AIDS Conferen

Porter DP, Bennett SR, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs [Poster 952]. Conference on Retroviruses and Opportunistic Infections (CROI); 2015 23-26 February; Seattle, WA.

Rakhmanina N, Gaur A, Natukunda E, Chokephaibulkit K, Liberty A, Kido A, et al. Acceptability and palatability of the single-tablet regimens of B/F/TAF and E/C/F/TAF in children (6-12 years) living with HIV infection [Abstract 33]. 10th International Work

Rakhmanina N, Natukunda E, Kosalaraksa P, Batra J, Gaur A, Shao Y, et al. Safety and efficacy of E/C/F/TAF in virologically suppressed, HIV-infected children through 48 weeks [Abstract 32]. 9th International Workshop on HIV Pediatrics; 2017 July 21-22; Pa

Sharma S, Gupta S, Majeed S, Strehlau R, Hellstrom E, Liu Y, et al. Exposure-Safety of Tenofovir in Pediatric HIV-Infected Participants: Comparison of Tenofovir Alafenamide & Tenofovir Disoproxil Fumarate [Abstract 23]. 10th International Workshop on HIV

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Primary	PK Parameter: AUCtau of EVG (Cohort 2)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Primary	PK Parameter: AUCtau of EVG (Cohort 3)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Primary	PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)	AUClast is defined as the concentration of drug from time zero to the last observable concentration.	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Primary	PK Parameter: AUClast of TAF (Cohort 2)	AUClast is defined as the concentration of drug from time zero to the last observable concentration.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Primary	PK Parameter: AUCtau of TAF (Cohort 3)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Primary	Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)	Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal; Life-threatening; Disabling/incapacitating; Results in hospitalization or prolongs a hospital stay; A congenital abnormality; Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.	From first dose date up to Week 24
Primary	Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs	TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal; Life-threatening; Disabling/incapacitating; Results in hospitalization or prolongs a hospital stay; A congenital abnormality; Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.	From first dose date up to Week 24
Primary	Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs	TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal; Life-threatening; Disabling/incapacitating; Results in hospitalization or prolongs a hospital stay; A congenital abnormality; Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.	From first dose date up to Week 24
Secondary	PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)	Ctau is defined as the observed drug concentration at the end of the dosing interval.	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary	PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)	Ctau is defined as the observed drug concentration at the end of the dosing interval.	(pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary	PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)	Ctau is defined as the observed drug concentration at the end of the dosing interval.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary	PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)	Cmax is defined as the maximum concentration of drug.	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary	PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)	Cmax is defined as the maximum concentration of drug.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary	PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)	Cmax is defined as the maximum concentration of drug.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary	PK Parameter: CL of EVG and TAF (Cohort 1)	Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary	PK Parameter: CL of EVG and TAF (Cohort 2)	Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary	PK Parameter: CL of EVG and TAF (Cohort 3)	Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary	PK Parameter: Vz of EVG and TAF (Cohort 1)	Vz is defined as the volume of distribution of the drug after intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary	PK Parameter: Vz of EVG and TAF (Cohort 2)	Vz is defined as the volume of distribution of the drug after intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary	PK Parameter: Vz of EVG and TAF (Cohort 3)	Vz is defined as the volume of distribution of the drug after intravenous administration.	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary	PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary	PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary	PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).	0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 24
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.	Week 48
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.	Week 48
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.	Week 48
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.	Week 24
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.	Week 48
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.	Week 48
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.	Week 24
Secondary	Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.	Week 48
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.	Week 48
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.	Week 24
Secondary	Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.	Week 48
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.	Week 24
Secondary	Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.	Week 48
Secondary	Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24		Baseline, Week 24
Secondary	Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48		Baseline, Week 48
Secondary	Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24		Baseline, Week 24
Secondary	Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48		Baseline, Week 48
Secondary	Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24		Baseline, Week 24
Secondary	Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48		Baseline, Week 48
Secondary	Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24		Baseline, Week 24
Secondary	Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48		Baseline, Week 48
Secondary	Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24		Baseline, Week 24
Secondary	Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48		Baseline, Week 48
Secondary	Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24		Baseline, Week 24
Secondary	Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48		Baseline, Week 48
Secondary	Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24		Baseline, Week 24
Secondary	Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48		Baseline, Week 48

External Links

•   Gilead Clinical Trials Website