Reducing mortality in adults with advanced HIV disease using azithromycin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Adama Hospital Medical College
  Ādama, Ethiopia Recruiting
• Asella Referral and Teaching Hospital
  Āsela, Ethiopia Recruiting
• Jimma University Hospital
  Jimma, Ethiopia Recruiting
• Kumasi South Hospital
  Kumasi, Ghana Recruiting
• Suntreso Government Hospital
  Kumasi, Ghana Recruiting
• University of Nigeria Teaching Hospital
  Enugu, Nigeria Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: John Eikelboom, MBBS, MSc, FRCPC — Population Health Research Institute
• Study coordinator: REVIVE Study Coordinator
• Email: revive@phri.ca
• Phone: 905-297-3479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.