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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: Completed Phase 3 study of HIV Infections and HIV, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01095796 record still lists
NCT01095796 is an interventional study that assigns participants to a tested intervention. The registered 707 participants enrollment target is mid-sized for trials with a published cap, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (59% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
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Where NCT01095796's enrollment target sits among peer trials
707 44th of 542 higher than 499 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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