At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 76 enrolled

Drug / intervention

Isotretinoindrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01969058

NCT01969058Phase 2Completed

Compare CT.gov

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)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Oct 25, 2013·Updated Oct 15, 2024

In Brief

A Phase 2 clinical trial evaluating Isotretinoin for HIV-1 Infection. Completed, enrolled 76 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV-1 Infection

CountriesPuerto Rico, United States

CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedOct 2013

Enrollment StartJul 2014

Primary CompletionAug 2016

Study CompletionNov 2016

TodayJul 2026

First PostedOct 25, 2013

Enrollment StartJul 2, 2014

Primary CompletionAug 31, 2016

Study CompletionNov 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 12.7 years ago

Interventions

Isotretinoindrug

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.