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. Total follow up duration will be 48 weeks.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Documented HIV infection
- CD4 count criteria:
- CD4 count ≤ 100 cells/mm3 within past 4 weeks; 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 4 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)
- Off-label azithromycin prophylaxis or requirement for prolonged (\> 7 days) azithromycin (or macrolide) therapy
