Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

Last updated: March 22, 2024
Sponsor: Population Health Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv/aids

Aids And Aids Related Infections

Hiv Infections

Treatment

Placebo oral tablet

Azithromycin Oral Tablet

Clinical Study ID

NCT05580666
PHRI.REVIVE
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ≥ 6months; 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 iffailing current therapy, within 4 weeks of enrolment

Exclusion

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 thejudgment of site investigators)
  3. Off-label azithromycin prophylaxis or requirement for prolonged (> 7 days)azithromycin (or macrolide) therapy

Study Design

Total Participants: 8000
Treatment Group(s): 2
Primary Treatment: Placebo oral tablet
Phase: 3
Study Start date:
May 08, 2023
Estimated Completion Date:
August 01, 2028

Study 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.

Connect with a study center

  • University of Botswana

    Gaborone,
    Botswana

    Site Not Available

  • Fondation Congolaise pour la Recherche Médicale

    Brazzaville,
    Congo

    Site Not Available

  • Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)

    Abidjan,
    Côte D'Ivoire

    Site Not Available

  • Centre de Prise en Charge et de Formation

    Abidjan,
    Côte D'Ivoire

    Site Not Available

  • Centre médical de suivi des donneurs de sang (CMSDS)

    Abidjan,
    Côte D'Ivoire

    Site Not Available

  • Unité de Soins Ambulatoires et de conseils (USAC)

    Abidjan,
    Côte D'Ivoire

    Site Not Available

  • Adama Hospital Medical College

    Ādama,
    Ethiopia

    Site Not Available

  • Komfo Anokye Teaching Hospital

    Kumasi,
    Ghana

    Site Not Available

  • Lilongwe Medical Relief Fund/UNC Project

    Lilongwe,
    Malawi

    Site Not Available

  • Faculty of Medicine, Eduardo Mondlane University

    Maputo,
    Mozambique

    Site Not Available

  • University of Abuja Teaching Hospital

    Abuja,
    Nigeria

    Site Not Available

  • University of Calabar Teaching Hospital

    Calabar,
    Nigeria

    Site Not Available

  • University of Nigeria Teaching Hospital

    Enugu,
    Nigeria

    Active - Recruiting

  • University College Hospital

    Ibadan,
    Nigeria

    Active - Recruiting

  • Jos University Teaching Hospital

    Jos,
    Nigeria

    Site Not Available

  • Aminu Kano Teaching Hospital

    Kano,
    Nigeria

    Site Not Available

  • Lagos University Teaching Hospital

    Lago,
    Nigeria

    Active - Recruiting

  • Usmanu Danfodiyo University Teaching Hos

    Sokoto,
    Nigeria

    Site Not Available

  • Federal Medical Center

    Umuahia,
    Nigeria

    Site Not Available

  • University of Uyo Teaching Hospital

    Uyo,
    Nigeria

    Site Not Available

  • Niger Delta University Teaching Hospital

    Yenagoa,
    Nigeria

    Site Not Available

  • Centre Hospitalier Universitaire de Kigali (CHUK)

    Kigali,
    Rwanda

    Site Not Available

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

    Freetown,
    Sierra Leone

    Active - Recruiting

  • Desmond Tutu Health Foundation

    Cape Town,
    South Africa

    Site Not Available

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

    Cape Town,
    South Africa

    Site Not Available

  • New Somerset Hospital

    Cape Town,
    South Africa

    Active - Recruiting

  • Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre

    Cape Town,
    South Africa

    Active - Recruiting

  • Africa Health Research Institute (AHRI)- Nkundusi Clinic

    Hlabisa,
    South Africa

    Site Not Available

  • Africa Health Research Institute (AHRI)- Hluhluwe Clinic

    Hluhluwe,
    South Africa

    Site Not Available

  • Wits Health Consortium (Pty) Ltd

    Johannesburg,
    South Africa

    Active - Recruiting

  • The Aurum Institute

    Klerksdorp,
    South Africa

    Site Not Available

  • Africa Health Research Institute (AHRI)- KwaMsane Clinic

    Mtubatuba,
    South Africa

    Site Not Available

  • Africa Health Research Institute (AHRI)- Mpukunyoni Clinic

    Mtubatuba,
    South Africa

    Site Not Available

  • Africa Health Research Institute (AHRI)- Mtubatuba Clinic

    Mtubatuba,
    South Africa

    Site Not Available

  • Africa Health Research Institute (AHRI)- Somkhele Clinic

    Mtubatuba,
    South Africa

    Site Not Available

  • Steve Biko Academic Hospital, University of Pretoria

    Pretoria,
    South Africa

    Active - Recruiting

  • Right to Care NPC, Esizayo Division

    Randburg,
    South Africa

    Active - Recruiting

  • The Aurum Institute

    Rustenburg,
    South Africa

    Site Not Available

  • National Institute for Medical Research (NIMR)

    Mbeya,
    Tanzania

    Site Not Available

  • Kibong'oto Infectious Diseases Hospital

    Moshi,
    Tanzania

    Site Not Available

  • Kilimanjaro Clinical Research Institute

    Moshi,
    Tanzania

    Site Not Available

  • Mbarara Regional Referral hospital

    Mbarara,
    Uganda

    Active - Recruiting

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

    Lusaka,
    Zambia

    Site Not Available

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

    Lusaka,
    Zambia

    Site Not Available

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

    Lusaka,
    Zambia

    Site Not Available

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