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

Gilead Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV

Treatments: Drug: E/C/F/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02276612

2014-002673-11 (EudraCT Number)

GS-US-292-1515

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

E/C/F/TAF

Experimental group

Description:

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.

Treatment:

Drug: E/C/F/TAF