Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01475838 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
A Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 438
- Enrollment target
- 20
- Study locations
NCT01475838 is a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome that has completed, run by Gilead Sciences. The registered enrollment target is 438 participants, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target. The trial reports 20 study locations across 4 states.
The verdict
NCT01475838, a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 438 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
Conditions Studied
Interventions
- DRUG FTC/TDF
- DRUG PI
- DRUG RTV
- DRUG Stribild
Study Locations (20)
California
- AIDS Healthcare Foundation - Beverly Hills
- Pacific Oaks Medical Group - Beverly Hills
- Kaiser Permanente - Hayward
- Kaiser Permanente - Los Angeles
- Peter J. Ruane, M.D., Inc. - Los Angeles
- OASIS Clinic - Los Angeles
- Anthony Mills MD Inc - Los Angeles
- Stanford University - Palo Alto
- University of California, Davis - Sacramento
- Kaiser Permanente - Sacramento
- La Playa Medical Group and Clinical Research - San Diego
- Metropolis Medical - San Francisco
- Kaiser Permanente San Francisco - San Francisco
Florida
- Gary Richmond, MD - Fort Lauderdale
- Midway Immunology & Research Center, LLC - Ft. Pierce
- The Kinder Medical Group - Miami
Arizona
- Spectrum Medical Group - Phoenix
- Pueblo Family Physicians - Phoenix
District of Columbia
- Dupont Circle Physicians Group, P.C - Washington D.C.
- Capital Medical Associates, PC - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01475838
The ClinicalTrials.gov registry entry for NCT01475838 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target. 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 FTC/TDF is the first listed.
NCT01475838 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01475838 about?
NCT01475838 is a clinical study titled "Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients". This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combin...
What is the current status of trial NCT01475838?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2011-11. Estimated completion is 2014-12.
What conditions does trial NCT01475838 study?
This clinical trial studies the following conditions: HIV Infections, Acquired Immunodeficiency Syndrome.
What interventions are being tested in trial NCT01475838?
The interventions under investigation include: FTC/TDF (DRUG), PI (DRUG), RTV (DRUG), Stribild (DRUG).
Who is sponsoring clinical trial NCT01475838?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01475838 being conducted?
This trial has 20 study locations across Arizona, California, 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 Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
RECRUITING · Phase 3
-
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
RECRUITING · Phase 3
-
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
RECRUITING · Phase 3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
ACTIVE NOT RECRUITING · Phase 3
-
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
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.