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Reducing mortality in adults with advanced HIV disease using azithromycin

Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial

Phase 3 Interventional Population Health Research Institute · NCT05580666

This study is testing if taking azithromycin can help adults with advanced HIV live longer by comparing it to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment8000 (estimated)
Ages18 Years and up
SexAll
SponsorPopulation Health Research Institute Academic / other
Locations52 sites (Abidjan and 51 other locations)
Trial IDNCT05580666 on ClinicalTrials.gov

What this trial studies

The REVIVE trial is a double-blinded, placebo-controlled, multicenter clinical trial designed to evaluate the effectiveness of azithromycin prophylaxis in reducing mortality among adults with advanced HIV disease. Participants will be randomly assigned to receive either azithromycin or a placebo for a duration of 28 days, followed by a 24-week monitoring period to assess outcomes. The total follow-up for each participant will last 48 weeks, allowing researchers to gather comprehensive data on the intervention's impact on mortality rates.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with documented HIV infection and specific CD4 count criteria indicating advanced disease.

Not a fit: Patients with contraindications to azithromycin or those requiring immediate hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly reduce mortality rates in adults suffering from advanced HIV disease.

How similar studies have performed: Previous studies have explored the use of azithromycin in various contexts, but this specific approach in advanced HIV disease is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Abidjan and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV Disease ProgressionHuman immunodeficiency virusAntiretroviral therapyAzithromycinMortality
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.