Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

• Status: Completed
• Trial end date: 2017-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Key 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)

• 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 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.