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Evaluating a Combination of Immune-based Therapies to Achieve a Remission of HIV Infection — HIVACAR  

HIV Infections Clinical Trial

Official title:
A Phase I/IIa, Randomised Study to Evaluate the Safety and the Effectiveness of a Combination of Therapeutic Vaccine, Broadly Neutralising Antibody (10-1074), and the Latency Reversing Agent Romidepsin to Achieve a Remission of HIV Infection in Chronically HIV-infected Participants Under Stable Combined Antiretroviral Therapy.

Clinical Trial Summary

A phase I/IIa, multinational, multicentric (IDIBAPS, IRSICAIXA, AARHUS, VUB, APHP), randomised, balanced by centre (to include participants from the 4 arms), open-label, controlled clinical trial. Each participant will be followed up a different time according to study arm: a minimum of 38 weeks in arm I, 31 weeks in arm II, 54 weeks in arm III and 26 weeks in the arm 4. The study duration will be 104 weeks from inclusion of the first participant.

Participants will be randomised to one of the following 4 arms:

- Arm 1 (study): 14 participants will receive 3 vaccines of HIVARNA01.3 prime, 2 MVA-vectored vaccine boosts, 1 dose of 10-1074 antibodies and 3 doses of romidepsin

- Arm 2 (study): 14 participants will receive 5 vaccines of HIVARNA01.3, 1 dose of 10-1074 antibodies and 3 doses of romidepsin

- Arm 3 (study): 14 participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 1 dose of 10-1074 antibodies and 3 doses of romidepsin

- Arm 4 (control): 14 participants 1 dose of 10-1074 antibodies and 3 doses of romidepsin

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03619278
Study type Interventional
Source Hospital Clinic of Barcelona
Contact Felipe Garcia, MD
Phone +93.227.54.00
Email fgarcia@clinic.cat
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date November 1, 2020
Completion date July 15, 2021
View Details
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