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Taking people in EthiopiaPhase 3

Tests azithromycin in adults with advanced HIV disease

Tests a daily pill against placebo in adults with advanced HIV disease.

Key facts

Who runs it
Population Health Research Institute
Where
Ādama, Āsela, Jimma, and Mek'ele, EthiopiaSee the 4 sitesAlso in 10 other countries, 48 sites
Trial code
Registry title
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Status
Recruiting
Phase
Phase 3
People taking part
8,000 people, planned
Started
8 May 2023
Expected to end
31 May 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Azithromycin Oral Tablet
  • Placebo oral tablet
Record updated
3 September 2025

Who can take part

AI summary

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

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Ethiopia

Also in 10 other countries, 48 sites

  • Adama Hospital Medical CollegeĀdama, EthiopiaContact: Endashaw A DebelaTaking people
  • Asella Referral and Teaching HospitalĀsela, EthiopiaContact: Gadisa D EjetaTaking people
  • Jimma University HospitalJimma, EthiopiaContact: Esayas K GudinaTaking people
  • Tigray health research institute (THRI)Mek'ele, EthiopiaContact: Hayelom BayrauNot yet recruiting

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Oral Azithromycin 250 mg once dailyTreatment being tested

    Active Azithromycin tablet

    Treatment: Azithromycin Oral Tablet

  • Oral matching placebo, once dailyPlacebo, for comparison

    Matching placebo tablet

    Treatment: Placebo oral tablet

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
Plain-language title
Tests azithromycin in adults with advanced HIV diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 September 2025