Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Recruiting · NCT05580666 · Interventional (participants receive a specific treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Azithromycin Oral TabletPlacebo oral tablet
What this trial is about
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
52 locations listed.
- 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
- University of Abuja Teaching Hospital - Abuja, Nigeria
- University of Calabar Teaching Hospital - Calabar, Nigeria
- 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
- University of Nigeria Teaching Hospital - Enugu, Nigeria
- 34 Military Hospital - Freetown, Sierra Leone
- College of Medicine and Allied Health Sciences, University of Sierra Leone - Freetown, Sierra Leone
- Africa Health Research Institute (AHRI)- Nkundusi Clinic - Hlabisa, South Africa
- Africa Health Research Institute (AHRI)- Hluhluwe Clinic - Hluhluwe, South Africa
- University College Hospital - Ibadan, Nigeria
- Jimma University Hospital - Jimma, Ethiopia
- Wits Health Consortium (Pty) Ltd - Johannesburg, South Africa
- Jos University Teaching Hospital - Jos, Nigeria
- MUJHU - Kampala, Uganda
- SICRA Kampala - Kampala, Uganda
- Aminu Kano Teaching Hospital - Kano, Nigeria
- Kenema Regional Hospital - Kenema, Sierra Leone
- Centre Hospitalier Universitaire de Kigali (CHUK) - Kigali, Rwanda
- The Aurum Institute - Klerksdorp, South Africa
- Koidu Government Hospital - Koidu, Sierra Leone
- Komfo Anokye Teaching Hospital - Kumasi, Ghana
- Kumasi South Hospital - Kumasi, Ghana
- Suntreso Government Hospital - Kumasi, Ghana
- Lagos University Teaching Hospital - Lago, Nigeria
- Lilongwe Medical Relief Fund/UNC Project - Lilongwe, Malawi
- SICRA Lira - Lira, 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
- Makeni Regional Hospital - Makeni, Sierra Leone
- Faculty of Medicine, Eduardo Mondlane University - Maputo, Mozambique
- Mbarara Regional Referral hospital - Mbarara, Uganda
- Tigray health research institute (THRI) - Mek'ele, Ethiopia
- 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
- 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
- Adama Hospital Medical College - Ādama, Ethiopia
- Asella Referral and Teaching Hospital - Āsela, Ethiopia