RecruitingPhase 3NCT05580666
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
Sponsor
Population Health Research Institute
Enrollment
8,000 participants
Start Date
May 8, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Age ≥ 18 years
- Documented HIV infection
- 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
- Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment
Exclusion Criteria5
- Contraindications to azithromycin:
- i. 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
Interventions
DRUGAzithromycin Oral Tablet
Antimicrobial therapy
DRUGPlacebo oral tablet
Inert ingredients
Locations(52)
View Full Details on ClinicalTrials.gov
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NCT05580666