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NCT01252940 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
- 20
- Study locations
NCT01252940 is a Phase 3 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 482 participants, above the 345-participant average among 71 other HIV-1-infection trials with a reported enrollment target (40% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT01252940, a Phase 3 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
Conditions Studied
Interventions
- DRUG FTC/RPV/TDF
- DRUG PI
- DRUG RTV
- DRUG NRTIs
Study Locations (20)
California
- AIDS Healthcare Foundation-Research Center - Beverly Hills
- Pacific Oaks Medical Group - Beverly Hills
- Center for Special Immunology - Costa Mesa
- Kaiser Permanente - Hayward
- The Living Hope Foundation - Long Beach
- Peter J. Ruane, MD, Inc. - Los Angeles
- Kaiser Permanente - Los Angeles
- Jeffrey Goodman Special Care Clinic - Los Angeles
- Oasis Clinic - Los Angeles
- Anthony Mills, MD Internal Medicine - Los Angeles
- Orange Coast Medical Group - Newport Beach
- Alameda County Medical Center - Oakland
- East Bay AIDS Center - Oakland
- Stanford University - Palo Alto
- University of California, Davis - Sacramento
- Kaiser Permanente - Sacramento
- La Playa Medical Group and Clinical Research - San Diego
Alabama
- University of Alabama - Birmingham - Birmingham
Arizona
- Spectrum Medical Group - Phoenix
Arkansas
- Health for Life Clinic, PLLC - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01252940
The ClinicalTrials.gov registry entry for NCT01252940 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 345-participant average among 71 other HIV-1-infection trials with a reported enrollment target (40% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which FTC/RPV/TDF is the first listed.
NCT01252940 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01252940 about?
NCT01252940 is a clinical study titled "Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF". The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative t...
What is the current status of trial NCT01252940?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2010-11. Estimated completion is 2014-10.
What conditions does trial NCT01252940 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT01252940?
The interventions under investigation include: FTC/RPV/TDF (DRUG), PI (DRUG), RTV (DRUG), NRTIs (DRUG).
Who is sponsoring clinical trial NCT01252940?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01252940 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
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