Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Documented HIV infection

3. CD4 count criteria:

i. 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

4. 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:

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)