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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02881320
Other study ID # GS-US-380-1474
Secondary ID 2016-002345-39
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 21, 2016
Est. completion date December 2024

Study information

Verified date May 2024
Source Gilead Sciences
Contact Gilead Study Team
Email GS-US-380-1474@gilead.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility Key Inclusion Criteria: Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight = 35 kg) who are virologically suppressed for = 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight = 25 kg) who are virologically suppressed for = 6 months prior to screening. Cohort 3: HIV-1 infected children (= 2 years of age and screening weight of = 14 to < 25 kg) who are virologically suppressed for = 6 months prior to screening. Cohort 4 Group 1: HIV-1 infected children (= 2 years of age and screening weight of = 14 to < 25 kg) who are virologically suppressed for = 6 months prior to screening and unable to swallow tablets. - Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL) for = 6 months preceding the Screening visit. Unconfirmed virologic elevations of = 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests. - Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen. - Estimated glomerular filtration rate (eGFR) = 90 mL/min/1.73 m^2 according to the Schwartz Formula. - No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I. Cohort 4 Group 2-4: HIV-1 infected children (= 1 month of age and screening weight of = 3 to < 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for = 1 month prior to screening. - Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age). - On a stable ARV regimen for = 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment). - For < 1 year of age, eGFR = the minimum normal values for age according to the information below using the Schwartz Formula, - 30 mL/min/1.73 m^2 for age > 4 weeks to = 95 days. - 39 mL/min/1.73 m^2 for age = 96 days to = 6 months. - 49 mL/min/1.73 m^2 for age > 6 months to < 12 months. - For = 1 year of age, eGFR = 90 mL/min/1.73 m^2 using the Schwartz Formula. - No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. - For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. Individuals with HIV-1 RNA > 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations. - Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, = 14 days prior to enrollment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (TOS)
2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.
B/F/TAF (TOS)
2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS)
1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS)
1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily

Locations

Country Name City State
South Africa Department of Paediatrics and Child Health Bloemfontein
South Africa Be Part Ypluntu Centre Cape Town
South Africa FAMCRU, Ward J8 CapeTown
South Africa Dr. J Fourie Medical Centre Dundee
South Africa Enhancing Care Foundation, Durban International Clinical Research Site Durban
South Africa Clinical HIV Research Unit(CHRU), Wits Health Consortium, Department of Medicine, University of the Witwatersrand Johannesburg
South Africa Empilweni Service and Research Unit (ESRU) Johannesburg
South Africa Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute Johannesburg
South Africa VX Pharma(Pty) Ltd Pretoria
South Africa Perinatal HIV Research Unit Soweto
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok
Thailand The HIV Netherlands Australia Thailand Research Collaboration Bangkok
Thailand Faculty of Medicine, Khon Kaen University Khon Kaen
Uganda Baylor College of Medicine Children's Foundation - Uganda Kampala
Uganda Joint Clinical Research Centre Kampala
Uganda Makerere University, Johns Hopkins (MU-JHU) Research Collaboration Kampala
United States Grady Health System Ponce Center Family and Youth Clinic Atlanta Georgia
United States Wayne Pediatric Clinic Detroit Michigan
United States Duke Children's Health Center, Pediatric Infectious Diseases Durham North Carolina
United States Midway Immunology and Research Center Fort Pierce Florida
United States University of Florida Health Gainesville Florida
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Bellevue Hospital New York New York
United States St. Christopher's Hospital for Children/Section of Immunology Philadelphia Pennsylvania
United States USF Clinic at Children's Medical Services (study visits and drug storage) Tampa Florida
United States Children's National Health System Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  South Africa,  Thailand,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary PK Parameter: AUCtau of Bictegravir AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary PK Parameter: Ctau of Bictegravir Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary PK Parameter: AUClast of TAF (Cohort 4) AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary PK Parameter: Cmax of TAF (Cohort 4) Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24 Up to 24 weeks
Primary Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 Up to 24 weeks
Secondary Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm Week 24
Secondary Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm Week 48
Secondary Change from Baseline in CD4+ Cell Counts at Week 24 Baseline, Week 24
Secondary Change from Baseline in CD4+ Cell Counts at Week 48 Baseline, Week 48
Secondary Change from Baseline in CD4+ Cell Count Percentages at Week 24 Baseline, Week 24
Secondary Change from Baseline in CD4+ Cell Count Percentages at Week 48 Baseline, Week 48
Secondary PK Parameter: Tmax of Bictegravir Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Cmax of Bictegravir Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: AUClast of Bictegravir AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: T1/2 of Bictegravir T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Apparent Clearance (CL) of Bictegravir CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Apparent Vz of Bictegravir Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: AUCtau of TAF and FTC AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3) AUClast is defined as the area under the concentration of drug from time zero to the last observable concentration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose
Secondary PK Parameter: AUClast of FTC (Cohorts 4) AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3) Cmax is defined as the maximum observed concentration of drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose
Secondary PK Parameter: Cmax of FTC (Cohorts 4) Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Ctau of TAF and FTC Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Tmax of TAF and FTC Tmax is defined as the time (observed time point) of Cmax. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: T1/2 of TAF and FTC T1/2 is defined as the estimate of the terminal elimination half-life of the drug. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Apparent CL of TAF and FTC CL is defined as the systemic clearance of the drug following study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary PK Parameter: Apparent Vz of TAF and FTC Vz is defined as the volume of distribution of the drug after study drug administration. Cohorts 1 & 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose.
Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose.
Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose.
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48 Up to 48 weeks
Secondary Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48 Up to 48 weeks
Secondary Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts) Participants or legal guardian will be asked:
if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3)
about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Day 1
Secondary Palatability of B/F/TAF Formulation at Day 1 (All Cohorts) Participants or legal guardian will be asked about the study drug taste (All Cohorts) Day 1
Secondary Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts) Participants or legal guardian will be asked:
if study drug shape and size were acceptable (for Cohort 1 and Cohort 2)
about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Week 4
Secondary Palatability of B/F/TAF Formulation at Week 4 (All Cohorts) Participants or legal guardian will be asked about the study drug taste (All Cohorts) Week 4
Secondary Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4) Participants or legal guardian will be asked:
about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Week 24
Secondary Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4) Participants or legal guardian will be asked about the study drug taste Week 24
Secondary Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4) Participants or legal guardian will be asked:
about ease of swallowability and the shape and size of study drug when swallowed (for Cohort 3).
about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste (for Cohort 4)
Week 48
Secondary Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4) Participants or legal guardian will be asked about the study drug taste Week 48
Secondary Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4) Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste Week 1
Secondary Palatability of B/F/TAF Formulation at Week 1 (Cohort 4) Participants or legal guardian will be asked about the study drug taste Week 1
Secondary Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4) Participants or legal guardian will be asked about their understanding of instructions, preparation of the study drug formulation and study drug administration and taste Week 2
Secondary Palatability of B/F/TAF Formulation at Week 2 (Cohort 4) Participants or legal guardian will be asked about the study drug taste Week 2
See also
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