Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

NCT05580666 | Recruiting Phase 3 DMC

• 1 other identifier: PHRI.REVIVE
• Study Type: interventional
• Target: 8,000
• Locations: 10 countries
• Sites: 49

Brief Summary

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

Conditions

HIV Disease Progression

Keywords

Human immunodeficiency virus; Antiretroviral therapy; Azithromycin; Mortality

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause mortality over the first 24 weeks after randomization

  24 weeks after randomization

Secondary Outcomes (3)

• All-cause mortality

  12 weeks after randomization

• Hospitalization

  24 weeks after randomization

• Composite of hospitalization or all-cause mortality

  24 weeks after randomization

Study Arms (2)

Oral Azithromycin 250 mg once daily

EXPERIMENTAL

Active Azithromycin tablet

Drug: Azithromycin Oral Tablet

Oral matching placebo, once daily

PLACEBO COMPARATOR

Matching placebo tablet

Drug: Placebo oral tablet

Interventions

Azithromycin Oral Tablet DRUG

Antimicrobial therapy

Oral Azithromycin 250 mg once daily

Placebo oral tablet DRUG

Inert ingredients

Oral matching placebo, once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Documented HIV infection
• 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
• Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment

You may not qualify if:

• Contraindications to azithromycin:
• i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or
• ii. Personal or family history of QT-prolongation
• Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)
• Off-label azithromycin prophylaxis or requirement for prolonged (\> 7 days) azithromycin (or macrolide) therapy

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (52)

Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)

Abidjan, Côte d’Ivoire

NOT YET RECRUITING

Centre médical de suivi des donneurs de sang (CMSDS)

Abidjan, Côte d’Ivoire

NOT YET RECRUITING

Unité de Soins Ambulatoires et de conseils (USAC)

Abidjan, Côte d’Ivoire

NOT YET RECRUITING

Adama Hospital Medical College

Ādama, Ethiopia

RECRUITING

Asella Referral and Teaching Hospital

Āsela, Ethiopia

RECRUITING

Jimma University Hospital

Jimma, Ethiopia

RECRUITING

Tigray health research institute (THRI)

Mek'ele, Ethiopia

NOT YET RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, Ghana

NOT YET RECRUITING

Kumasi South Hospital

Kumasi, Ghana

RECRUITING

Suntreso Government Hospital

Kumasi, Ghana

RECRUITING

Lilongwe Medical Relief Fund/UNC Project

Lilongwe, Malawi

NOT YET RECRUITING

Faculty of Medicine, Eduardo Mondlane University

Maputo, Mozambique

NOT YET RECRUITING

University of Abuja Teaching Hospital

Abuja, Nigeria

NOT YET RECRUITING

University of Calabar Teaching Hospital

Calabar, Nigeria

NOT YET RECRUITING

University of Nigeria Teaching Hospital

Enugu, Nigeria

RECRUITING

University College Hospital

Ibadan, Nigeria

RECRUITING

Jos University Teaching Hospital

Jos, Nigeria

ACTIVE NOT RECRUITING

Aminu Kano Teaching Hospital

Kano, Nigeria

NOT YET RECRUITING

Lagos University Teaching Hospital

Lago, Nigeria

RECRUITING

Usmanu Danfodiyo University Teaching Hos

Sokoto, Nigeria

ACTIVE NOT RECRUITING

Federal Medical Center

Umuahia, Nigeria

NOT YET RECRUITING

University of Uyo Teaching Hospital

Uyo, Nigeria

ACTIVE NOT RECRUITING

Niger Delta University Teaching Hospital

Yenagoa, Nigeria

NOT YET RECRUITING

Centre Hospitalier Universitaire de Kigali (CHUK)

Kigali, Rwanda

NOT YET RECRUITING

34 Military Hospital

Freetown, Sierra Leone

RECRUITING

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

Freetown, Sierra Leone

RECRUITING

Kenema Regional Hospital

Kenema, Sierra Leone

RECRUITING

Koidu Government Hospital

Koidu, Sierra Leone

RECRUITING

Makeni Regional Hospital

Makeni, Sierra Leone

RECRUITING

Desmond Tutu Health Foundation

Cape Town, South Africa

NOT YET RECRUITING

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

Cape Town, South Africa

NOT YET RECRUITING

New Somerset Hospital

Cape Town, South Africa

RECRUITING

Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre

Cape Town, South Africa

RECRUITING

Africa Health Research Institute (AHRI)- Nkundusi Clinic

Hlabisa, South Africa

NOT YET RECRUITING

Africa Health Research Institute (AHRI)- Hluhluwe Clinic

Hluhluwe, South Africa

NOT YET RECRUITING

Wits Health Consortium (Pty) Ltd

Johannesburg, South Africa

RECRUITING

The Aurum Institute

Klerksdorp, South Africa

NOT YET RECRUITING

Africa Health Research Institute (AHRI)- KwaMsane Clinic

Mtubatuba, South Africa

NOT YET RECRUITING

Africa Health Research Institute (AHRI)- Mpukunyoni Clinic

Mtubatuba, South Africa

NOT YET RECRUITING

Africa Health Research Institute (AHRI)- Mtubatuba Clinic

Mtubatuba, South Africa

NOT YET RECRUITING

Africa Health Research Institute (AHRI)- Somkhele Clinic

Mtubatuba, South Africa

NOT YET RECRUITING

Livingstone hospital

Port Elizabeth, South Africa

RECRUITING

Steve Biko Academic Hospital, University of Pretoria

Pretoria, South Africa

RECRUITING

Right to Care NPC, Esizayo Division

Randburg, South Africa

COMPLETED

The Aurum Institute

Rustenburg, South Africa

NOT YET RECRUITING

MUJHU

Kampala, Uganda

RECRUITING

SICRA Kampala

Kampala, Uganda

RECRUITING

SICRA Lira

Lira, Uganda

RECRUITING

Mbarara Regional Referral hospital

Mbarara, Uganda

RECRUITING

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

Lusaka, Zambia

NOT YET RECRUITING

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

Lusaka, Zambia

NOT YET RECRUITING

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

Lusaka, Zambia

NOT YET RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• John Eikelboom, MBBS, MSc, FRCPC

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Sean Wasserman, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

REVIVE Study Coordinator

CONTACT

905-297-3479; revive@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded placebo-controlled randomized trial

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: May 8, 2023
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); NG (11); ZA (16); RW (1); CÔ (3); ET (4); UG (4); GH (3); SI (5); MO (1)