Overview
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Description
All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Documented HIV infection
- CD4 count criteria:
- CD4 count ≤ 100 cells/mm3 within past 30 days if on ART; or
ii. Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or
iii. Documented CD4 count ≤ 100 cells/mm3 if ART-naive
- Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 2 weeks of enrolment
Exclusion Criteria:
- Contraindications to azithromycin:
- Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or
ii. Personal or family history of QT-prolongation
- Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)