Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

NCT ID: NCT05580666

Last Updated: 2025-09-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2029-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Disease Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded placebo-controlled randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blinded placebo-controlled

Study Groups

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Oral Azithromycin 250 mg once daily

Active Azithromycin tablet

Group Type EXPERIMENTAL

Azithromycin Oral Tablet

Intervention Type DRUG

Antimicrobial therapy

Oral matching placebo, once daily

Matching placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Inert ingredients

Interventions

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Azithromycin Oral Tablet

Antimicrobial therapy

Intervention Type DRUG

Placebo oral tablet

Inert ingredients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Centre médical de suivi des donneurs de sang (CMSDS)

Abidjan, , Côte d’Ivoire

Site Status NOT_YET_RECRUITING

Unité de Soins Ambulatoires et de conseils (USAC)

Abidjan, , Côte d’Ivoire

Site Status NOT_YET_RECRUITING

Adama Hospital Medical College

Ādama, , Ethiopia

Site Status RECRUITING

Asella Referral and Teaching Hospital

Āsela, , Ethiopia

Site Status RECRUITING

Jimma University Hospital

Jimma, , Ethiopia

Site Status RECRUITING

Tigray health research institute (THRI)

Mek'ele, , Ethiopia

Site Status NOT_YET_RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, , Ghana

Site Status NOT_YET_RECRUITING

Kumasi South Hospital

Kumasi, , Ghana

Site Status RECRUITING

Suntreso Government Hospital

Kumasi, , Ghana

Site Status RECRUITING

Lilongwe Medical Relief Fund/UNC Project

Lilongwe, , Malawi

Site Status NOT_YET_RECRUITING

Faculty of Medicine, Eduardo Mondlane University

Maputo, , Mozambique

Site Status NOT_YET_RECRUITING

University of Abuja Teaching Hospital

Abuja, , Nigeria

Site Status NOT_YET_RECRUITING

University of Calabar Teaching Hospital

Calabar, , Nigeria

Site Status NOT_YET_RECRUITING

University of Nigeria Teaching Hospital

Enugu, , Nigeria

Site Status RECRUITING

University College Hospital

Ibadan, , Nigeria

Site Status RECRUITING

Jos University Teaching Hospital

Jos, , Nigeria

Site Status ACTIVE_NOT_RECRUITING

Aminu Kano Teaching Hospital

Kano, , Nigeria

Site Status NOT_YET_RECRUITING

Lagos University Teaching Hospital

Lago, , Nigeria

Site Status RECRUITING

Usmanu Danfodiyo University Teaching Hos

Sokoto, , Nigeria

Site Status ACTIVE_NOT_RECRUITING

Federal Medical Center

Umuahia, , Nigeria

Site Status NOT_YET_RECRUITING

University of Uyo Teaching Hospital

Uyo, , Nigeria

Site Status ACTIVE_NOT_RECRUITING

Niger Delta University Teaching Hospital

Yenagoa, , Nigeria

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Kigali (CHUK)

Kigali, , Rwanda

Site Status NOT_YET_RECRUITING

34 Military Hospital

Freetown, , Sierra Leone

Site Status RECRUITING

College of Medicine and Allied Health Sciences, University of Sierra Leone

Freetown, , Sierra Leone

Site Status RECRUITING

Kenema Regional Hospital

Kenema, , Sierra Leone

Site Status RECRUITING

Koidu Government Hospital

Koidu, , Sierra Leone

Site Status RECRUITING

Makeni Regional Hospital

Makeni, , Sierra Leone

Site Status RECRUITING

Desmond Tutu Health Foundation

Cape Town, , South Africa

Site Status NOT_YET_RECRUITING

Groote Schuur Hospital -New main building, Infectious Disease Clinic G26

Cape Town, , South Africa

Site Status NOT_YET_RECRUITING

New Somerset Hospital

Cape Town, , South Africa

Site Status RECRUITING

Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre

Cape Town, , South Africa

Site Status RECRUITING

Africa Health Research Institute (AHRI)- Nkundusi Clinic

Hlabisa, , South Africa

Site Status NOT_YET_RECRUITING

Africa Health Research Institute (AHRI)- Hluhluwe Clinic

Hluhluwe, , South Africa

Site Status NOT_YET_RECRUITING

Wits Health Consortium (Pty) Ltd

Johannesburg, , South Africa

Site Status RECRUITING

The Aurum Institute

Klerksdorp, , South Africa

Site Status NOT_YET_RECRUITING

Africa Health Research Institute (AHRI)- KwaMsane Clinic

Mtubatuba, , South Africa

Site Status NOT_YET_RECRUITING

Africa Health Research Institute (AHRI)- Mpukunyoni Clinic

Mtubatuba, , South Africa

Site Status NOT_YET_RECRUITING

Africa Health Research Institute (AHRI)- Mtubatuba Clinic

Mtubatuba, , South Africa

Site Status NOT_YET_RECRUITING

Africa Health Research Institute (AHRI)- Somkhele Clinic

Mtubatuba, , South Africa

Site Status NOT_YET_RECRUITING

Livingstone hospital

Port Elizabeth, , South Africa

Site Status RECRUITING

Steve Biko Academic Hospital, University of Pretoria

Pretoria, , South Africa

Site Status RECRUITING

Right to Care NPC, Esizayo Division

Randburg, , South Africa

Site Status COMPLETED

The Aurum Institute

Rustenburg, , South Africa

Site Status NOT_YET_RECRUITING

MUJHU

Kampala, , Uganda

Site Status RECRUITING

SICRA Kampala

Kampala, , Uganda

Site Status RECRUITING

SICRA Lira

Lira, , Uganda

Site Status RECRUITING

Mbarara Regional Referral hospital

Mbarara, , Uganda

Site Status RECRUITING

The Center for Infectious Disease Research in Zambia (CIDRZ)- George Clinical Research Site

Lusaka, , Zambia

Site Status NOT_YET_RECRUITING

The Center for Infectious Disease Research in Zambia (CIDRZ)- Matero Clinical Research Site

Lusaka, , Zambia

Site Status NOT_YET_RECRUITING

The Center for Infectious Disease Research in Zambia (CIDRZ)-Chawama Clinical Research Site (CRS)

Lusaka, , Zambia

Site Status NOT_YET_RECRUITING

Countries

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Côte d’Ivoire Ethiopia Ghana Malawi Mozambique Nigeria Rwanda Sierra Leone South Africa Uganda Zambia

Central Contacts

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REVIVE Study Coordinator

Role: CONTACT

905-297-3479

Facility Contacts

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Henri Chenal

Role: primary

Albert Minga

Role: primary

Serge Koule

Role: primary

Endashaw A Debela

Role: primary

Gadisa D Ejeta

Role: primary

Esayas K Gudina

Role: primary

Hayelom Bayrau

Role: primary

Yasmine Hardy

Role: primary

Daniel O Minkah

Role: primary

Sheila Bawa

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

Stephen Sevalie

Role: primary

Daniel Sesay

Role: primary

Abdulai T Jalloh

Role: primary

Mohamed I Marah

Role: primary

Matilda Kamara

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

Denise Kyazze

Role: primary

Veronica Ueckermann

Role: primary

William L Brumskine

Role: primary

Brenda C Kakayi

Role: primary

Lydia Nakiyingi

Role: primary

Francis Kiweewa

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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