A Phase IIA Randomized Double-blind Placebo-controlled Single-centre Study of the Effect of Bacillus Calmette-Guérin (BCG) Vaccination on the HIV Latent Reservoir (BELIEVE)

NCT05004038 Phase 2 COMPLETED

A phase IIA randomized double-blind placebo-controlled single-centre study of the effect of Bacillus Calmette-Guérin (BCG) vaccination on the HIV latent reservoir

Details

Lead sponsor	University of Zurich
Phase	Phase 2
Status	COMPLETED
Enrolment	60
Start date	2022-01-04
Completion	2023-09-01

Conditions

• HIV-1-infection

Interventions

• BCG Vaccine AJVaccines

Primary outcomes

• Change in size of the HIV-1 latent reservoir at 6 months — 6 months for each patient
  The primary outcome will be the change in size of the HIV-1 latent reservoir at 6 months post-BCG vaccination compared to pre-vaccination in all patients, with each patient serving as their own control. This HIV-1 latent reservoir size will be measured as total HIV-1 DNA in peripheral blood mononuclear cells, a well-established and extensively validated marker for the HIV-1 reservoir found to be sensitive, clinically relevant and feasible in larger populations.

Countries

Switzerland