Trial intelligence / Profile preview

REDUC: Vacc-4x and Romidepsin in HIV-1

NCT02092116Phase 2

Key facts

Status
Completed
Start
Mar 2014
Primary completion
Aug 2015
Countries
1
Sponsor
Immunor
Modality
Peptides, Small Molecules, Vaccines & Immunotherapeutics
Conditions
human immunodeficiency virus type 1 infection (HIV-1)
01

Overview

Phase 2, open-label trial of Vacc-4x and romidepsin in human immunodeficiency virus type 1 infection (HIV-1) (2 arms), sponsored by Immunor. Primary endpoints: Number of Participants With Adverse Events and Serious Adverse Events at 3 weeks and Changes From Baseline in HIV-1 Reservoir at Day 175. Started Mar 2014; status: completed.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Part A: Romidepsin

    Romidepsin alone for safety and reactivation assessment

  • Part B: Vacc-4x + Romidepsin

    Vacc-4x immunization followed by Romidepsin reactivation

03

Endpoints

Primary

  • Number of Participants With Adverse Events and Serious Adverse Events

  • Changes From Baseline in HIV-1 Reservoir

Secondary

  • Changes From Baseline in HIV-1 Reservoir

  • Number of Participants With Adverse Events and Serious Adverse Events

  • Level of HIV-1 Transcription

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