HIV-1 Infection Clinical Trial
Official title:
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
Verified date | May 2024 |
Source | Gilead Sciences |
Contact | Gilead Study Team |
GS-US-380-1474[@]gilead.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, South Africa, Thailand, Uganda,
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 |
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