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Completed

NCT Number: NCT02092116

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

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.

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Key information

Conditions

HIV I Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aarhus University Hospital, Skejby Sygehus

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Currently receiving cART and having received cART for a minimum of 1 year
  • HIV-1 plasma RNA <50 copies/mL for at least 1 year (excluding viral load blips)
  • CD4 T cell count ≥500 cells/mm3

Exclusion criteria

  • CD4 T cell count nadir <200 cells/mm3
  • Previous treatment with an HDACi (Histone deacetylase inhibitor) within the previous 6 months
  • 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
  • Use of any protocol defined contraindicated medication or vaccination
  • Unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol.
  • Males or females who are unwilling or unable to use protocol defined methods of contraception

Treatment and study plan

Romidepsin

Drug

Latency reversing agent

Other names: Istodax®

Vacc-4x

Biological

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

Other names: A combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13

rhuGM-CSF

Biological

Granulocyte macrophage colony stimulating factor as a local adjuvant

Other names: Leukine®

Primary outcomes

  1. Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: 3 weeks

    Safety and tolerability evaluation as measured by adverse events (AE) and serious adverse events (SAE).

  2. Part B: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus.

    Time frame: Day 161/175

    Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.

    Blood samples were obtained at Day 0, Day 105 and Day 161.

Secondary outcomes

  1. Part A: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus. Estimates of Change From Baseline of the Size of the Latent HIV-1 Reservoir in CD4+ Cells.

    Time frame: Day 56/84

    Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.

    Total HIV-1 DNA was measured at Day 84

  2. Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: 287 days

    Safety and tolerability evaluation of romidepsin and Vacc-4x in combination with GM-CSF as measured by adverse events (AE) and serious adverse events (SAE).

  3. Part B: Level of HIV-1 Transcription.

    Time frame: Day 105, 112 and 119

    At day 105, 112 and 119 patients receive romidepsin and 4 hours after each administration HIV transcription is measured as unspliced HIV-1 RNA.

Sponsors and collaborators

Lead sponsor

Bionor Immuno AS

Industry

Collaborators

  • Celgene Corporation

Registry information

Official study 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

Acronym: REDUC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2014
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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