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BCG Vaccination Effect on Latent Reservoir Size in Treated HIV-1 Infection:

CompletedPhase 2

Sponsor: University of Zurich

Conditions: HIV-1-infection

Interventions: BCG Vaccine AJVaccines

Countries: Switzerland

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Zurich, Switzerland