NCT02092116

Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bionor Immuno AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is divide into two parts. In Part A the safety and tolerability of romidepsin will be evaluated and the effect of romidepsin treatment on HIV-1 transcription in HIV-infected patients virologically suppressed on cART will be determined. In Part B the effect of treatment with Vacc-4x + rhuGM-CSF and romidepsin treatment on the HIV-1 latent reservoir in HIV-infected patients virologically suppressed on cART will be measured. Six patients will be enrolled for part A and the safety and tolerability profile evaluated before enrolling 20 patients in B.

Conditions

• HIV I Infection

Interventions

Type	Name	Description
DRUG	Romidepsin	Latency reversing agent
BIOLOGICAL	Vacc-4x	Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
BIOLOGICAL	rhuGM-CSF	Granulocyte macrophage colony stimulating factor as a local adjuvant

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2014-03-19
• Last updated: 2017-03-01
• Results posted: 2017-03-01

Locations

1 site across 1 country: Denmark