Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
NCT ID: NCT05580666
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
8000 participants
INTERVENTIONAL
2023-05-08
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral Azithromycin 250 mg once daily
Active Azithromycin tablet
Azithromycin Oral Tablet
Antimicrobial therapy
Oral matching placebo, once daily
Matching placebo tablet
Placebo oral tablet
Inert ingredients
Interventions
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Azithromycin Oral Tablet
Antimicrobial therapy
Placebo oral tablet
Inert ingredients
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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John Eikelboom, MBBS, MSc, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Sean Wasserman, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)
Abidjan, , Côte d’Ivoire
Centre médical de suivi des donneurs de sang (CMSDS)
Abidjan, , Côte d’Ivoire
Unité de Soins Ambulatoires et de conseils (USAC)
Abidjan, , Côte d’Ivoire
Adama Hospital Medical College
Ādama, , Ethiopia
Asella Referral and Teaching Hospital
Āsela, , Ethiopia
Jimma University Hospital
Jimma, , Ethiopia
Tigray health research institute (THRI)
Mek'ele, , Ethiopia
Komfo Anokye Teaching Hospital
Kumasi, , Ghana
Kumasi South Hospital
Kumasi, , Ghana
Suntreso Government Hospital
Kumasi, , Ghana
Lilongwe Medical Relief Fund/UNC Project
Lilongwe, , Malawi
Faculty of Medicine, Eduardo Mondlane University
Maputo, , Mozambique
University of Abuja Teaching Hospital
Abuja, , Nigeria
University of Calabar Teaching Hospital
Calabar, , Nigeria
University of Nigeria Teaching Hospital
Enugu, , Nigeria
University College Hospital
Ibadan, , Nigeria
Jos University Teaching Hospital
Jos, , Nigeria
Aminu Kano Teaching Hospital
Kano, , Nigeria
Lagos University Teaching Hospital
Lago, , Nigeria
Usmanu Danfodiyo University Teaching Hos
Sokoto, , Nigeria
Federal Medical Center
Umuahia, , Nigeria
University of Uyo Teaching Hospital
Uyo, , Nigeria
Niger Delta University Teaching Hospital
Yenagoa, , Nigeria
Centre Hospitalier Universitaire de Kigali (CHUK)
Kigali, , Rwanda
34 Military Hospital
Freetown, , Sierra Leone
College of Medicine and Allied Health Sciences, University of Sierra Leone
Freetown, , Sierra Leone
Kenema Regional Hospital
Kenema, , Sierra Leone
Koidu Government Hospital
Koidu, , Sierra Leone
Makeni Regional Hospital
Makeni, , Sierra Leone
Desmond Tutu Health Foundation
Cape Town, , South Africa
Groote Schuur Hospital -New main building, Infectious Disease Clinic G26
Cape Town, , South Africa
New Somerset Hospital
Cape Town, , South Africa
Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre
Cape Town, , South Africa
Africa Health Research Institute (AHRI)- Nkundusi Clinic
Hlabisa, , South Africa
Africa Health Research Institute (AHRI)- Hluhluwe Clinic
Hluhluwe, , South Africa
Wits Health Consortium (Pty) Ltd
Johannesburg, , South Africa
The Aurum Institute
Klerksdorp, , South Africa
Africa Health Research Institute (AHRI)- KwaMsane Clinic
Mtubatuba, , South Africa
Africa Health Research Institute (AHRI)- Mpukunyoni Clinic
Mtubatuba, , South Africa
Africa Health Research Institute (AHRI)- Mtubatuba Clinic
Mtubatuba, , South Africa
Africa Health Research Institute (AHRI)- Somkhele Clinic
Mtubatuba, , South Africa
Livingstone hospital
Port Elizabeth, , South Africa
Steve Biko Academic Hospital, University of Pretoria
Pretoria, , South Africa
Right to Care NPC, Esizayo Division
Randburg, , South Africa
The Aurum Institute
Rustenburg, , South Africa
MUJHU
Kampala, , Uganda
SICRA Kampala
Kampala, , Uganda
SICRA Lira
Lira, , Uganda
Mbarara Regional Referral hospital
Mbarara, , Uganda
The Center for Infectious Disease Research in Zambia (CIDRZ)- George Clinical Research Site
Lusaka, , Zambia
The Center for Infectious Disease Research in Zambia (CIDRZ)- Matero Clinical Research Site
Lusaka, , Zambia
The Center for Infectious Disease Research in Zambia (CIDRZ)-Chawama Clinical Research Site (CRS)
Lusaka, , Zambia
Countries
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Central Contacts
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Facility Contacts
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Henri Chenal
Role: primary
Albert Minga
Role: primary
Serge Koule
Role: primary
Yasmine Hardy
Role: primary
Cecilia Kanyama
Role: primary
Albertino Damasceno
Role: primary
Vivian Kwaghe
Role: primary
Bassey Ekeng
Role: primary
Uchechukwu Unigwe
Role: primary
Olukemi Adekanmbi
Role: primary
Garba Iliyasu
Role: primary
Lorhen Akase
Role: primary
Chiedozie Maduka
Role: primary
Dimie Ogoina
Role: primary
Leopold Bitunguhari
Role: primary
Daniel Sesay
Role: primary
Chantel Schreuder
Role: primary
Phiona Namale
Role: primary
Nicolene Le Roux
Role: primary
Leigh Wagner
Role: primary
Lucica D Thaver
Role: primary
Alungile N Fileyo
Role: primary
Tom Boyles
Role: primary
James C Innes
Role: primary
Alungile N Fileyo
Role: primary
Sune Liebetrau
Role: primary
Lucica D Thaver
Role: primary
Ngcebo Mhlongo
Role: primary
Veronica Ueckermann
Role: primary
William L Brumskine
Role: primary
Keneth Kananura
Role: primary
Masuzyo Chrwa
Role: primary
Ethel Kamuti
Role: primary
Katanekwa Njekwa
Role: primary
Other Identifiers
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PHRI.REVIVE
Identifier Type: -
Identifier Source: org_study_id
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