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Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
NCT02071082 · View on ClinicalTrials.gov ↗
Study Summary
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive * Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
Interventions
- DRUG E/C/F/TAF
Study Locations (20)
Florida
- Barry M. Rodwick MD — Clearwater
- Gary J Richmond M.D.,P.A. — Fort Lauderdale
- Midway Immunology and Research Center — Ft. Pierce
- AIDS Health Foundation/WPA — Miami Beach
- AIDS Research and Treatment Center of the Treasure Coast — Vero Beach
- Triple O Research Institute PA — West Palm Beach
Texas
- Central Texas Clinical Research — Austin
- St. Hope Foundation — Bellaire
- North Texas Infectious Diseases Consultants — Dallas
- Therapeutic Concepts — Houston
- Gordon E. Crofoot MD PA — Houston
California
- AHF Research Center — Beverly Hills
- Peter J. Ruane MD, Inc. — Los Angeles
- Anthony Mills MD, Inc — Los Angeles
Missouri
- KC Care Clinic — Kansas City
- Southampton Healthcare, Inc. — St Louis
Arizona
- Spectrum Medical Group — Phoenix
District of Columbia
- Whitman Walker Health — Washington D.C.
Michigan
- Be Well Medical Center PC — Berkley
New Mexico
- Southwest CARE Center — Santa Fe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-02-25 |
| Est. Completion | 2016-10-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071082
The ClinicalTrials.gov registry entry for NCT02071082 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention — of which E/C/F/TAF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02071082 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02071082 about?
NCT02071082 is a clinical study titled "Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults". This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * C...
What is the current status of trial NCT02071082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2014-02-25. Estimated completion is 2016-10-26.
What conditions does trial NCT02071082 study?
This clinical trial studies the following conditions: HIV, HBV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02071082?
The interventions under investigation include: E/C/F/TAF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02071082?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02071082 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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