Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363011
The ClinicalTrials.gov registry entry for NCT01363011 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 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 (76% 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 5 interventions - of which ATV is the first listed.
NCT01363011 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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
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.