Trials / Completed
CompletedNCT01969058
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
A Prospective Randomized Controlled Study to Evaluate the Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery on Suppressive Antiretroviral Therapy (ART)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Isotretinoin was administered to participants in the Isotretinoin arm at approximately 0.5 mg/kg PO once daily for 4 weeks, then increased to approximately 1.0 mg/kg PO once daily for 12 weeks. Follow-up continues to week 28 to evaluate the duration of effect. Randomization was stratified by willingness to participate in the gut biopsy substudy, A5330s. The study population included HIV-1 infected adults whose virus was suppressed on ART, excluding women of child bearing potential.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isotretinoin | Isotretinoin is a drug that is approved for use in the treatment of severe acne. The aim of this study is to evaluate the role of Isotretinoin on immune activation and inflammation. |
Timeline
- Start date
- 2014-07-02
- Primary completion
- 2016-08-31
- Completion
- 2016-11-01
- First posted
- 2013-10-25
- Last updated
- 2024-10-15
- Results posted
- 2017-09-05
Locations
15 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01969058. Inclusion in this directory is not an endorsement.