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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 17
Updated:11/21/2018
Start Date:December 3, 2014
End Date:October 23, 2017

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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

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.


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.
We found this trial at
5
sites
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Cape Town,
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Detroit, MI
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Tampa, FL
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