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NCT01095796 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 3 study of HIV Infections and HIV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 707
- Enrollment target
- 20
- Study locations
NCT01095796 is a Phase 3 study of HIV Infections and HIV that has completed, run by Gilead Sciences. The registered enrollment target is 707 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT01095796, a Phase 3 study of HIV Infections and HIV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 707 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
Conditions Studied
Interventions
- DRUG Stribild
- DRUG Atripla
- DRUG Stribild Placebo
- DRUG Atripla Placebo
Study Locations (20)
California
- AHF Research Center - Beverly Hills
- Kaiser Permanente Hospital - Hayward
- Living Hope Clinical Foundation - Long Beach
- Kaiser Permanente - Los Angeles
- Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic - Los Angeles
- UCLA Center for Clinical Aids Research and Education - Los Angeles
- Peter J. Ruane, MD, Inc. - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Anthony Mills, MD, Inc. - Los Angeles
- Orange Coast Medical Group - Newport Beach
- Alameda County Medical Center - Oakland
- East Bay AIDS Center - Oakland
- Stanford University - Palo Alto
- Kaiser Permanente Medical Group - Sacramento
- La Playa Medical Group and Clinical Research - San Diego
- San Francisco General Hospital, University of California, San Francisco - San Francisco
- Metropolis Medical - San Francisco
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Spectrum Medical Group - Phoenix
Arkansas
- Health for Life Clinic PLLC - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 707 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01095796
The ClinicalTrials.gov registry entry for NCT01095796 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 707 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (59% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Stribild is the first listed.
NCT01095796 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01095796 about?
NCT01095796 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-nai...
What is the current status of trial NCT01095796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 707 participants. The study started on 2010-03. Estimated completion is 2014-09.
What conditions does trial NCT01095796 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT01095796?
The interventions under investigation include: Stribild (DRUG), Atripla (DRUG), Stribild Placebo (DRUG), Atripla Placebo (DRUG).
Who is sponsoring clinical trial NCT01095796?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01095796 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.