CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Romidepsin +2 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.

Search/NCT02092116
NCT02092116Phase 2Completed

An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization Using Vacc-4x + rhuGM-CSF and HIV-1 Reactivation Using Romidepsin on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART

Bionor Immuno AS·interventional·Posted Mar 19, 2014·Updated Mar 1, 2017

In Brief

A Phase 2 clinical trial evaluating Romidepsin, Vacc-4x, and 1 other intervention for HIV I Infection. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV I Infection
CountriesDenmark
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 19, 2014
Enrollment StartMar 1, 2014
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.3 years ago

Interventions

Romidepsindrug

Latency reversing agent

Vacc-4xbiological

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSFbiological

Granulocyte macrophage colony stimulating factor as a local adjuvant