Reducing Mortality in Adults With Advanced HIV Disease (REVIVE) (REVIVE)

August 26, 2025 updated by: Population Health Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

8000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: REVIVE Study Coordinator
  • Phone Number: 905-297-3479
  • Email: revive@phri.ca

Study Locations

  • Côte d’Ivoire
      • Abidjan, Côte d’Ivoire
        • Not yet recruiting
        • Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)
        • Contact:
          • Henri Chenal
      • Abidjan, Côte d’Ivoire
        • Not yet recruiting
        • Centre Médical de Suivi des donneurs de sang (CMSDS)
        • Contact:
          • Albert Minga
      • Abidjan, Côte d’Ivoire
        • Not yet recruiting
        • Unité de Soins Ambulatoires et de conseils (USAC)
        • Contact:
          • Serge Koule
  • Ethiopia
      • Jimma, Ethiopia
      • Mek'ele, Ethiopia
        • Not yet recruiting
        • Tigray health research institute (THRI)
        • Contact:
      • Ādama, Ethiopia
      • Āsela, Ethiopia
        • Recruiting
        • Asella Referral and Teaching Hospital
        • Contact:
  • Ghana
      • Kumasi, Ghana
        • Not yet recruiting
        • Komfo Anokye Teaching Hospital
        • Contact:
          • Yasmine Hardy
      • Kumasi, Ghana
      • Kumasi, Ghana
        • Recruiting
        • Suntreso Government Hospital
        • Contact:
  • Malawi
      • Lilongwe, Malawi
        • Not yet recruiting
        • Lilongwe Medical Relief Fund/UNC Project
        • Contact:
          • Cecilia Kanyama
  • Mozambique
      • Maputo, Mozambique
        • Not yet recruiting
        • Faculty of Medicine, Eduardo Mondlane University
        • Contact:
          • Albertino Damasceno
  • Nigeria
      • Abuja, Nigeria
        • Not yet recruiting
        • University of Abuja Teaching Hospital
        • Contact:
          • Vivian Kwaghe
      • Calabar, Nigeria
        • Not yet recruiting
        • University of Calabar Teaching Hospital
        • Contact:
          • Bassey Ekeng
      • Enugu, Nigeria
        • Recruiting
        • University of Nigeria Teaching Hospital
        • Contact:
          • Uchechukwu Unigwe
      • Ibadan, Nigeria
        • Recruiting
        • University College Hospital
        • Contact:
          • Olukemi Adekanmbi
      • Jos, Nigeria
        • Active, not recruiting
        • Jos University Teaching Hospital
      • Kano, Nigeria
        • Not yet recruiting
        • Aminu Kano Teaching Hospital
        • Contact:
          • Garba Iliyasu
      • Lago, Nigeria
        • Recruiting
        • Lagos University Teaching Hospital
        • Contact:
          • Lorhen Akase
      • Sokoto, Nigeria
        • Active, not recruiting
        • Usmanu Danfodiyo University Teaching Hos
      • Umuahia, Nigeria
        • Not yet recruiting
        • Federal Medical Center
        • Contact:
          • Chiedozie Maduka
      • Uyo, Nigeria
        • Active, not recruiting
        • University of Uyo Teaching Hospital
      • Yenagoa, Nigeria
        • Not yet recruiting
        • Niger Delta University Teaching Hospital
        • Contact:
          • Dimie Ogoina
  • Rwanda
      • Kigali, Rwanda
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Kigali (CHUK)
        • Contact:
          • Leopold Bitunguhari
  • Sierra Leone
      • Freetown, Sierra Leone
        • Recruiting
        • College of Medicine and Allied Health Sciences, University of Sierra Leone
        • Contact:
          • Daniel Sesay
      • Freetown, Sierra Leone
      • Kenema, Sierra Leone
      • Koidu, Sierra Leone
        • Recruiting
        • Koidu Government Hospital
        • Contact:
      • Makeni, Sierra Leone
  • South Africa
      • Cape Town, South Africa
        • Recruiting
        • New Somerset Hospital
        • Contact:
          • Nicolene Le Roux
      • Cape Town, South Africa
        • Not yet recruiting
        • Desmond Tutu Health Foundation
        • Contact:
          • Chantel Schreuder
      • Cape Town, South Africa
        • Not yet recruiting
        • Groote Schuur Hospital -New main building, Infectious Disease Clinic G26
        • Contact:
          • Phiona Namale
      • Cape Town, South Africa
        • Recruiting
        • Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre
        • Contact:
          • Leigh Wagner
      • Hlabisa, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- Nkundusi Clinic
        • Contact:
          • Lucica D Thaver
      • Hluhluwe, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- Hluhluwe Clinic
        • Contact:
          • Alungile N Fileyo
      • Johannesburg, South Africa
        • Recruiting
        • Wits Health Consortium (Pty) Ltd
        • Contact:
          • Tom Boyles
      • Klerksdorp, South Africa
        • Not yet recruiting
        • The Aurum Institute
        • Contact:
          • James C Innes
      • Mtubatuba, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- KwaMsane Clinic
        • Contact:
          • Alungile N Fileyo
      • Mtubatuba, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- Mpukunyoni Clinic
        • Contact:
          • Sune Liebetrau
      • Mtubatuba, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- Mtubatuba Clinic
        • Contact:
          • Lucica D Thaver
      • Mtubatuba, South Africa
        • Not yet recruiting
        • Africa Health Research Institute (AHRI)- Somkhele Clinic
        • Contact:
          • Ngcebo Mhlongo
      • Port Elizabeth, South Africa
      • Pretoria, South Africa
        • Recruiting
        • Steve Biko Academic Hospital, University of Pretoria
        • Contact:
          • Veronica Ueckermann
      • Randburg, South Africa
        • Completed
        • Right to Care NPC, Esizayo Division
      • Rustenburg, South Africa
        • Not yet recruiting
        • The Aurum Institute
        • Contact:
          • William L Brumskine
  • Uganda
      • Kampala, Uganda
      • Kampala, Uganda
      • Lira, Uganda
      • Mbarara, Uganda
        • Recruiting
        • Mbarara Regional Referral Hospital
        • Contact:
          • Keneth Kananura
  • Zambia
      • Lusaka, Zambia
        • Not yet recruiting
        • The Center for Infectious Disease Research in Zambia (CIDRZ)- George Clinical Research Site
        • Contact:
          • Masuzyo Chrwa
      • Lusaka, Zambia
        • Not yet recruiting
        • The Center for Infectious Disease Research in Zambia (CIDRZ)- Matero Clinical Research Site
        • Contact:
          • Ethel Kamuti
      • Lusaka, Zambia
        • Not yet recruiting
        • The Center for Infectious Disease Research in Zambia (CIDRZ)-Chawama Clinical Research Site (CRS)
        • Contact:
          • Katanekwa Njekwa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Azithromycin 250 mg once daily
Active Azithromycin tablet
Drug: Azithromycin Oral Tablet
Antimicrobial therapy
Placebo Comparator: Oral matching placebo, once daily
Matching placebo tablet
Drug: Placebo oral tablet
Inert ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 24 weeks after randomization
All-cause mortality over the first 24 weeks after randomization
24 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 weeks after randomization
All-cause mortality over the first 12 weeks after randomization
12 weeks after randomization
Hospitalization
Time Frame: 24 weeks after randomization
Hospitalization over the first 24 weeks after randomization
24 weeks after randomization
Composite of hospitalization or all-cause mortality
Time Frame: 24 weeks after randomization
Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization
24 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Sean Wasserman, MBChB, PhD, University of Cape Town
  • Principal Investigator: John Eikelboom, MBBS, MSc, FRCPC, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRI.REVIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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