Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00869557 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 2 study of HIV Infections and HIV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 20
- Study locations
NCT00869557 is a Phase 2 study of HIV Infections and HIV that has completed, run by Gilead Sciences. The registered enrollment target is 71 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT00869557, a Phase 2 study of HIV Infections and HIV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
Conditions Studied
Interventions
- DRUG Stribild
- DRUG Atripla
Study Locations (20)
Florida
- Broward Health - Fort Lauderdale
- Gary Richmond, MD, PA, Inc. - Fort Lauderdale
- Wohlfeiler, Piperato and Associates, LLC - Miami Beach
- Orlando Immunology Center - Orlando
- Infectious Disease of Central Florida - Orlando
- Treasure Coast Infectious Disease Consultants - Vero Beach
California
- The Living Hope Foundation - Long Beach
- Peter J. Ruane, MD, Inc. - Los Angeles
- Orange Coast Medical Group - Newport Beach
- East Bay AIDS Center - Oakland
- Metropolis Medical - San Francisco
District of Columbia
- Dupont Circle Physicians Group - Washington D.C.
- Whitman Walker Clinic - Washington D.C.
- Capital Medical Associates PC - Washington D.C.
Arkansas
- Health for Life Clinic, PLLC - Little Rock
Colorado
- Apex Research Institute - Denver
Georgia
- Infectious Disease Specialists of Atlanta (IDSA) - Decatur
Illinois
- Northstar Medical Center - Chicago
Maryland
- Chase Brexton Health Services, Inc. - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00869557
The ClinicalTrials.gov registry entry for NCT00869557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% 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 Infections appearing as the primary indexed condition, and to 2 interventions - of which Stribild is the first listed.
NCT00869557 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00869557 about?
NCT00869557 is a clinical study titled "Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) ver...
What is the current status of trial NCT00869557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2009-04. Estimated completion is 2013-09.
What conditions does trial NCT00869557 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT00869557?
The interventions under investigation include: Stribild (DRUG), Atripla (DRUG).
Who is sponsoring clinical trial NCT00869557?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00869557 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
RECRUITING · Phase 2
-
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
RECRUITING · Phase 2
-
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
RECRUITING · Phase 2
-
Imaging Immune Activation in HIV by PET-MR
RECRUITING · Phase 2
-
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
ACTIVE NOT RECRUITING · Phase 2
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.