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COMPLETED Phase 3

Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

NCT01363011 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 106 participants
Start Date 2011-05
Est. Completion 2015-02
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01363011 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01363011?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial