Trial record 2 of 223743 for:
B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children
Verified August 2016 by Gilead Sciences
Information provided by (Responsible Party):
First received: August 23, 2016
Last updated: August 25, 2016
Last verified: August 2016
The primary objectives of this study are to evaluate the steady state pharmacokinetics (PK) for bictegravir (GS-9883) and confirm the dose of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age). This study will also evaluate the safety and tolerability of B/F/TAF FDC through Week 24 in HIV-1 infected, virologically suppressed adolescents and children.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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 Virologically Suppressed Adolescents and Children
Primary Outcome Measures:
- PK Parameter: AUCtau of Bictegravir [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter: Ctau of Bictegravir [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Ctau is defined as the observed drug concentration at the end of the dosing interval.
- Incidence of Treatment-Emergent Adverse Events (AEs) Through Week 24 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- Incidence of Treatment-Emergent Laboratory Abnormalities Through Week 24 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Change from Baseline in CD4+ Cell Counts at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Change from Baseline in CD4+ Cell Count Percentages at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- PK Parameter: Tmax of Bictegravir [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Tmax is defined as the time (observed time point) of Cmax.
- PK Parameter: Cmax of Bictegravir [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Cmax is defined as the maximum observed concentration of drug.
- Incidence of Treatment-Emergent AEs Through Week 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
- Incidence of All Treatment-Emergent Laboratory Abnormalities Through Week 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
- Acceptability/Palatability of Adult and Age-Appropriate B/F/TAF Formulation [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
Participants will be asked if the study drug was palatable and if they were able to take the dosage form.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2017 (Final data collection date for primary outcome measure)
Cohort 1 (12 to < 18 years of age ≥ 35 kg)
- Part A: Participate in an Intensive PK evaluation at Week 4 and continue to receive B/F/TAF 50/200/25 mg FDC through Week 48.
- Part B: Following confirmation of PK data from Cohort 1 Part A, participants will receive B/F/TAF 50/200/25 mg FDC through Week 48.
Cohort 2 (6 to < 12 years of age)
- Part A: Participate in an Intensive PK evaluation at Week 4 and continue to receive B/F/TAF FDC through Week 48.
- Part B: Depending on PK data obtained from Cohort 2 Part A, participants may receive a different age-appropriate dose and formulation of B/F/TAF. Details will be provided in a future protocol amendment.
Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF FDC until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.
Tablet administered orally once daily without regard to food
Other Name: GS-9883/F/TAF
|Ages Eligible for Study:
||6 Years to 17 Years (Child)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- HIV-1 infected adolescents and children who are virologically suppressed for ≥ 6 months on a stable regimen
- Cohort 1 only: 12 to < 18 years old and weight at screening ≥ 35 kg (77 lbs)
- Cohort 2 only: 6 to < 12 years old
- Documented plasma HIV-1 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 (GFR) ≥ 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02881320
||Cheryl Pikora, MD
ClinicalTrials.gov processed this record on August 25, 2016
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 23, 2016
||August 25, 2016
||United States: Food and Drug Administration
Thailand: Food and Drug Administration
Uganda: National Drug Authority
South Africa: Medicines Control Council