BCG Vaccination Effect on Latent Reservoir Size in Treated HIV-1 Infection: (BELIEVE)
HIV-1-infection
About this trial
This is an interventional treatment trial for HIV-1-infection
Eligibility Criteria
Inclusion Criteria:
- Informed consent as documented by signature (see Informed Consent Form),
- Age ≥18 years,
- HIV-1 infection under continuous antiretroviral therapy for ≥1.5 years as requested in the Systems X Cohort,
- Current participation in the Swiss HIV Cohort Study and past participation in the Systems X Cohort.
Exclusion Criteria:
- History of virological failure or treatment interruption at any time, defined as HIV-1 viral load >200c/ml at two consecutive measurements at least 4 weeks apart,
- CD4 T-cell count <200/μl at any time or <350/μl during the past 1 year
- Presence of other relevant immunosuppression according to the investigator in addition to HIV (a daily steroid intake of ≥20mg is considered clinically relevant),
- History of or current clinical evidence of active tuberculosis,
- Previous positive tuberculin skin test or tuberculosis INF-gamma release assay (Quantiferon-Test) within the past 10 years,
- Previous BCG-vaccination within the past 10 years,
- Known allergy to BCG vaccine or any of its components,
- Documented current febrile illness at screening or in the past 7 days.
- Women who are pregnant or breast-feeding
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Early Group
Late Group
We will conduct a randomized, double-blind trial using a stepped-wedge design and involving a total of 60 patients with stable treated HIV and suppressed viral load who will all receive the BCG vaccine during the course of the study. Patients will be divided into two groups of equal size (early and late groups regarding administration of the BCG verum). The trial will be placebo-controlled and double-blind. Patients in the early group will receive the BCG verum at the beginning of Treatment Phase 1, and then the placebo at the beginning of Treatment Phase 2.
Patients in the late group will receive placebo at the beginning of Treatment Phase 1 and then the BCG verum at the beginning of Treatment Phase 2.