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NCT02071082 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

A Phase 3 study of HIV and HBV, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
79
Enrollment target
20
Study locations

NCT02071082 is a Phase 3 study of HIV and HBV that has completed, run by Gilead Sciences. The registered enrollment target is 79 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT02071082, a Phase 3 study of HIV and HBV, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
79 participants
Enrollment target
20
Study locations

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

Conditions Studied

HIV HBV

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

FieldValue
Enrollment Target 79 participants
Start Date 2014-02-25
Est. Completion 2016-10-26
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

Interested in This Trial?

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, categorized as Phase 3. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (82% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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.

NCT02071082 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Texas, California.

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.

What interventions are being tested in trial NCT02071082?

The interventions under investigation include: E/C/F/TAF (DRUG).

Who is sponsoring clinical trial NCT02071082?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.