Safety and Effect of the Histone Deacetylase Inhibitor Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV Reservoir

• Conditions: HIV-infection; MedDRA version: 17.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-004747-23-DK
• Lead Sponsor: Bionor Pharma ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-17
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified