Phase 3
Completed N=60
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
Source: ClinicalTrials.gov NCT02276612 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Feb 2018
Primary outcomePrimary: Incidence of Treatment-Emergent Serious Adverse Events — 4.0; 0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Serious Adverse Events |
4.0; 0 | — |
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
92.0; 100.0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) |
96.0; 100.0 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) |
90.0; 100.0 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 24 |
-72; -85 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 48 |
-43; -41 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 24 |
-0.6; -0.6 | — |
| SECONDARY Change From Baseline in CD4 Percentage at Week 48 |
-0.1; -1.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
- Weight ≥ 35 kg (77 lbs.)
- Plasma HIV-1 RNA levels 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.
Data sourced from ClinicalTrials.gov (NCT02276612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.