At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
Romidepsin +1 moredrug
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.
A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 2, 2013·Updated Nov 1, 2021
In Brief
A Phase 2 clinical trial evaluating Romidepsin and Placebo for Romidepsin for HIV Infections. Completed, enrolled 59 participants across 10 sites.
Detailed Summary
Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot cure HIV infection because a small amount of virus remains in cells as a hidden (latent) form. The purpose of this study was to evaluate the safety and efficacy of single dose and multiple dose administration of romidepsin (RMD) in HIV-infected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartMay 2014
Primary CompletionApr 2018
TodayJul 2026
First PostedSep 2, 2013
Enrollment StartMay 5, 2014
Primary CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.8 years ago
Interventions
Romidepsindrug
RMD administered over 4 hours via an intravenous (IV) catheter.
Placebo for Romidepsindrug
Placebo for RMD administered over 4 hours via an IV catheter.