RecruitingPhase 3NCT05580666

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

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

Sponsor

Population Health Research Institute

Enrollment

8,000 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

HIV Disease Progression

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a preventive antibiotic (azithromycin) to standard HIV treatment can reduce serious illness and death in adults with advanced HIV disease and very low immune cell counts. You may be eligible if: - You are 18 years or older - You have a confirmed HIV diagnosis - Your CD4 count (a measure of immune strength) is very low — specifically 100 cells/mm³ or below — either now or in your recent history - You are able to start, restart, or switch to an effective HIV treatment regimen within 4 weeks of joining the study You may NOT be eligible if: - You have a known allergy to azithromycin, erythromycin, or related antibiotics - You or a family member have a history of a dangerous heart rhythm condition called QT prolongation - You are seriously ill and need immediate ongoing hospital care - You are already taking azithromycin for prevention, or need a prolonged course of azithromycin or a similar antibiotic for another reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin Oral Tablet

Antimicrobial therapy

DRUGPlacebo oral tablet

Inert ingredients

Locations(52)

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

View Full Details on ClinicalTrials.gov

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NCT05580666