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COMPLETED Phase 2

Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery

NCT01969058 · View on ClinicalTrials.gov ↗

Study Summary

This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system. The immune system helps the body fight infections. When the immune system is not working well, one may be at greater risk for diseases that are common in aging, like heart disease, weaker bones, and kidney disease.

Conditions Studied

Interventions

  • DRUG Isotretinoin

Study Locations (15)

California

  • 601 University of California, Los Angeles CARE Center CRS — Los Angeles
  • 801 University of California, San Francisco HIV/AIDS CRS — San Francisco

Massachusetts

  • 101 Massachusetts General Hospital (MGH) CRS — Boston
  • 107 Brigham and Women's Hosp. ACTG CRS — Boston

North Carolina

  • 3201 Chapel Hill CRS — Chapel Hill
  • 3203 Greensboro CRS — Greensboro

Alabama

  • 31788 Alabama CRS — Birmingham

Missouri

  • 2101 Washington University Therapeutics (WT) CRS — St Louis

New Jersey

  • 31786 New Jersey Medical School Clinical Research Center CRS — Newark

New York

  • 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS — Rochester

Ohio

  • 2401 Cincinnati CRS — Cincinnati

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2014-07-02
Est. Completion 2016-11
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01969058

The ClinicalTrials.gov registry entry for NCT01969058 describes a study currently listed as completed. It is categorized as Phase 2, 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 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV-1 Infection appearing as the primary indexed condition, and to 1 intervention — of which Isotretinoin 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: NCT01969058 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, North Carolina. 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 NCT01969058 about?

NCT01969058 is a clinical study titled "Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery". This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system. The immune system helps the body fight infections. When the immune system is not working...

What is the current status of trial NCT01969058?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2014-07-02. Estimated completion is 2016-11.

What conditions does trial NCT01969058 study?

This clinical trial studies the following conditions: HIV-1 Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01969058?

The interventions under investigation include: Isotretinoin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01969058?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01969058 being conducted?

This trial has 15 study locations across Alabama, California, Massachusetts, Missouri, New Jersey. 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