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NCT01969058 · ClinicalTrials.gov registry record · Phase 2
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
A Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 15
- Study locations
NCT01969058: Completed Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT01969058 is a Phase 2 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 76 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (78% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01969058, a Phase 2 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16. Change = (week 14/16 - baseline).
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
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2014-07-02 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT01969058 record still lists
NCT01969058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (78% lower).
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.
NCT01969058 lists 15 locations in 12 states (California, Massachusetts, North Carolina).
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.
What interventions are being tested in trial NCT01969058?
The interventions under investigation include: Isotretinoin (DRUG).
Who is sponsoring clinical trial NCT01969058?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01969058's enrollment target sits among peer trials
76 37th of 71 higher than 34 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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