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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-03

Study Completion Date

2017-10-23

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

E/C/F/TAF

Intervention Type DRUG

150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Interventions

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E/C/F/TAF

150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Intervention Type DRUG

Other Intervention Names

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Genvoya®

Eligibility Criteria

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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.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No