Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
- Registration Number
- NCT02276612
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
- Weight ≥ 35 kg (77 lbs.)
- Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
- CD4+ cell count > 100 cells/μL
- No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- No evidence of current hepatitis B virus (HBV) infection
- No evidence of current hepatitis C virus (HCV) infection
Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.
Key
- A new AIDS-defining condition diagnosed within the 30 days prior to Screening
- Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
- Pregnant or lactating subjects
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E/C/F/TAF E/C/F/TAF Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks. After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Serious Adverse Events Up to Week 48 The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Incidence of Treatment-Emergent Adverse Events Up to Week 48 The percentage of participants experiencing any treatment-emergent adverse event was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) Week 24 The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient'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.
Change From Baseline in CD4 Percentage at Week 24 Baseline; Week 24 Change From Baseline in CD4 Cell Count at Week 24 Baseline; Week 24 Change From Baseline in CD4 Cell Count at Week 48 Baseline; Week 48 Change From Baseline in CD4 Percentage at Week 48 Baseline; Week 48 Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) Week 48 The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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.