Phase 2 N=26 Treatment

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

HIV I Infection

Bottom Line

View on ClinicalTrials.gov: NCT02092116 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Mar 2017

Primary outcome: Primary: Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — 6; 6; 1; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Romidepsin (Drug); Vacc-4x (Biological); rhuGM-CSF (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bionor Immuno AS
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	6; 6; 1; 6; 3	—
PRIMARY 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.	-39.71; -19.21; -38	—
SECONDARY 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.	791.7; 718.8; 2825.6; 4846.9; 0.39; 0.43	—
SECONDARY Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	1; 20; 1; 20; 5; 1	—
SECONDARY Part B: Level of HIV-1 Transcription.	6.95; 12.77; 22.98; 25.91	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02092116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.