Status:
COMPLETED
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
Lead Sponsor:
Gilead Sciences
Conditions:
HIV
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
PHASE3
Brief 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 adole...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02276612
Start Date
December 3 2014
End Date
October 23 2017
Last Update
November 19 2018
Active Locations (7)
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1
Tampa, Florida, United States
2
Detroit, Michigan, United States
3
New York, New York, United States
4
Memphis, Tennessee, United States