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ClinicalTrials.gov ID

NCT05580666

Lead Sponsor

Population Health Research InstituteOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

8,000Estimated

Last Update Posted

Sep 3, 2025Actual

Start Date

May 8, 2023Actual

Primary Completion Date

Nov 30, 2028Estimated

Completion Date

May 31, 2029Estimated

Official Title

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

Brief Summary

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

Detailed Description

All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure. Total follow up duration will be 48 weeks.

• HIV Disease Progression

• Azithromycin Oral Tablet
• Placebo oral tablet

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Population Health Research InstituteOTHER

bkakayi@mujhu.org

lydiakiyingi@gmail.com

fkiweewa@sicra.org