Overview

This trial is active, not recruiting.

Condition chronic hiv-infection
Treatments romidepsin (istodax®), vacc-4x, rhugm-csf (leukine®)
Phase phase 1/phase 2
Sponsor Bionor Immuno AS
Collaborator Celgene Corporation
Start date March 2014
End date August 2015
Trial size 26 participants
Trial identifier NCT02092116, 2013-004747-23, PBC01-001

Summary

The REDUC ("Kick and Kill") 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 ("Kick") 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 ("Kill") the infected cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Part A, to confirm a safe/tolerable and efficacious dose of romidepsin in HIV patients in a small cohort (n=6)
romidepsin (istodax®)
(Other)
Part B, to evaluate the safety/tolerability of Vacc-4x + rhuGM-CSF as adjunctive therapy to romidepsin and to assess the impact on the latent HIV reservoir and the ability to control viral load during an Analytical Treatment Interruption (n=20).
romidepsin (istodax®)
vacc-4x
rhugm-csf (leukine®)

Primary Outcomes

Measure
Primary endpoint Part A
time frame: Part A 12 weeks
Primary endpoint Part B
time frame: Part B Week 41
Primary endpoint Part B
time frame: Part B Week 41
Primary endpoint Part B
time frame: Part B Week 41

Secondary Outcomes

Measure
Secondary endpoints Part A
time frame: Part A 12 weeks
Secondary endpoints Part A
time frame: Part A 12 weeks
Secondary endpoints Part A
time frame: Part A 12 weeks
Secondary endpoints Part A
time frame: Part A 12 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endpoints Part B
time frame: Part B 41 weeks
Secondary Endponts Part B
time frame: Part B 41 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age >18 years 2. Currently receiving cART and having received cART for a minimum of 1 year 3. HIV-1 plasma RNA <50 copies/mL for at least 1 year (excluding viral load blips) 4. CD4 T cell count ≥500 cells/mm3 Exclusion Criteria: 1. CD4 T cell count nadir <200 cells/mm3 2. Previous treatment with an HDACi (Histone deacetylase inhibitor) within the previous 6 months 3. Any evidence of an active AIDS-defining opportunistic infection, active HBV or HCV co-infection, significant cardiac disease, malignancy, transplantation, insulin dependent diabetes mellitus or other protocol defined excluded medical condition 4. Use of any protocol defined contraindicated medication or vaccination 5. Unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol. 6. Males or females who are unwilling or unable to use protocol defined methods of contraception

Additional Information

Official title 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
Principal investigator Lars Jørgen Østergaard, MD, PhD, DMSc, Professor
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Bionor Immuno AS.