Overview

This trial is active, not recruiting.

Condition hiv
Treatment e/c/f/taf
Phase phase 2/phase 3
Sponsor Gilead Sciences
Start date December 2014
End date September 2017
Trial size 60 participants
Trial identifier NCT02276612, GS-US-292-1515

Summary

This study will assess the safety, efficacy and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive open-label E/C/F/TAF for up to 96 weeks followed by an optional open-label extension phase.
e/c/f/taf
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally once daily with food

Primary Outcomes

Measure
Incidence of treatment-emergent adverse events and serious adverse events
time frame: Up to 96 weeks plus 30 days

Secondary Outcomes

Measure
Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL (FDA snapshot analysis)
time frame: Weeks 24, 48, and 96
Change from baseline in CD4 cell count and CD4 percentage
time frame: Baseline; Weeks 24, 48, and 96

Eligibility Criteria

Male or female participants from 12 years up to 17 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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 - Hepatitis B or Hepatitis C virus infection

Additional Information

Official title A Phase 2/3 Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.