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NCT01363011 · ClinicalTrials.gov registry record · Phase 3
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
A Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT01363011: Completed Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.
NCT01363011 is a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome that has completed, run by Gilead Sciences. The registered enrollment target is 106 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363011, a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.
Primary Outcome
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).
Conditions Studied
Interventions
- DRUG ATV
- DRUG DRV
- DRUG E/C/F/TDF
- DRUG COBI
- DRUG NRTI
Study Locations (20)
California
- AHF Research Center - Beverly Hills
- Kaiser Permanente - Los Angeles
- Peter J. Ruane, M.D., Inc. - Los Angeles
- Anthony Mills, MD, Inc. - Los Angeles
- Orange Coast Medical Group - Newport Beach
- East Bay AIDS Center - Oakland
- University of California, Davis - Sacramento
- Metropolis Medical - San Francisco
Florida
- Therafirst Medical Center - Fort Lauderdale
- Broward Health - Fort Lauderdale
- Gary J. Richmond.M.D.,P.A. - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- Orlando Immunology Center - Orlando
- IDOCF/ValueHealthMD, LLC - Orlando
District of Columbia
- Whitman Walker Clinic - Washington D.C.
- Medical Faculty Associates - Washington D.C.
Arizona
- Spectrum Medical Group - Phoenix
Arkansas
- Health for Life Clinic - Little Rock
Colorado
- National Jewish Health - Denver
Connecticut
- Yale University School of Medicine AIDS Program - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01363011 record still lists
NCT01363011 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which ATV is the first listed.
NCT01363011 names 20 study sites across 7 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01363011 about?
NCT01363011 is a clinical study titled "Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment". This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.
What is the current status of trial NCT01363011?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2011-05. Estimated completion is 2015-02.
What conditions does trial NCT01363011 study?
This clinical trial studies the following conditions: HIV Infections, Acquired Immunodeficiency Syndrome.
What interventions are being tested in trial NCT01363011?
The interventions under investigation include: ATV (DRUG), DRV (DRUG), E/C/F/TDF (DRUG), COBI (DRUG), NRTI (DRUG).
Who is sponsoring clinical trial NCT01363011?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01363011 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01363011's enrollment target sits among peer trials
106 257th of 542 higher than 285 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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