Tests azithromycin in adults with advanced HIV disease
Tests a daily pill against placebo in adults with advanced HIV disease.
Plain-language title generated from the registry record
Registry title: Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Key facts
- Where
- Maputo, MozambiqueSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced HIV and a very low CD4 count. It tests azithromycin against a placebo to see if it lowers deaths.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced HIV with a CD4 count of 100 cells/mm3 or lower, as measured in the past 4 weeks, or at its lowest point in the past with ART stopped for at least 6 months, or in people who never took ART
- Earlier treatment
- People who never took ART can join. People who stopped ART completely for at least 6 months can also join. Azithromycin prophylaxis outside the label is not allowed.
- Biomarker or test result
- Documented HIV infection; CD4 count of 100 cells/mm3 or lower
Main reasons for not taking part
- Allergy to azithromycin, erythromycin or any macrolide antibiotic
- Personal or family history of QT-prolongation
- Severe illness needing hospital care now or soon, as judged by the site investigators
- Needing azithromycin or a macrolide for more than 7 days
- Not able to start, restart or switch ART within 4 weeks of enrolment
Read by machine on 9 November 2026.
Where in Mozambique
- Faculty of Medicine, Eduardo Mondlane UniversityMaputo, MozambiqueNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Population Health Research Institute
- Trial code
- NCT05580666
- Record updated
- 3 September 2025
- Original description
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.Read full original descriptionShow less
Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Inclusion: Age ≥ 18 years; Documented HIV infection; CD4 count criteria:; CD4 count ≤ 100 cells/mm3 within past 4 weeks; or; Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or; 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: Off-label azithromycin prophylaxis or requirement for prolonged (> 7 days) azithromycin (or macrolide) therapy; Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators); Contraindications to azithromycin:; Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or; Personal or family history of QT-prolongation.