Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals
NCT02616874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-05-07
Summary
The BCN02-Romi study aims to evaluate a combined "kick and kill" strategy using the most immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal agent available at present time (romidepsin) in a cohort of early-treated HIV positive individuals.
Conditions
Interventions
- DRUG
-
MVA.HIVconsv vaccine
Dose: 2x10e8 pfu, Interval: weeks 0 and 9.
- DRUG
-
Romidepsin
Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5
Sponsors & Collaborators
-
Germans Trias i Pujol Hospital
collaborator OTHER -
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
collaborator OTHER -
Hospital Clinic of Barcelona
collaborator OTHER -
Hospital de Sant Pau
collaborator OTHER -
HIVACAT
collaborator UNKNOWN -
University of Oxford
collaborator OTHER -
BCN Checkpoint
collaborator INDUSTRY -
IrsiCaixa
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2016-09-30
- Completion
- 2017-10-30
Countries
- Spain
Study Locations
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