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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: Completed Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Conditions Studied

HIV Infections Acquired Immunodeficiency Syndrome

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

FieldValue
Enrollment Target 438 participants
Start Date 2011-11
Est. Completion 2014-12
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT01475838 record still lists

NCT01475838 is an interventional study that assigns participants to a tested intervention. The registered 438 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target.

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 names 20 study sites across 4 states, led by 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.

Where NCT01475838's enrollment target sits among peer trials

438 77th of 542 higher than 466 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01475838, the US trial registry maintained by the National Library of Medicine. NCT01475838 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.