Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Trial Parameters
Brief Summary
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Documented HIV infection 3. CD4 count criteria: i. 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 4. 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: 1. Contraindications to azithromycin: i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or ii. Personal or family history of QT-prolongation 2. Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators) 3. Off-label azithromycin prophylaxis or requirement for prolonged (\> 7 days) azithromycin (or macrolide) therapy