Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

HIV Disease Progression Clinical Trial

— REVIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580666
• Other study ID #: PHRI.REVIVE
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2023
• Est. completion date: August 1, 2028

Study information

• Verified date: March 2024
• Source: Population Health Research Institute
• Contact: REVIVE Study Coordinator
• Phone: 905-297-3479
• Email: revive[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: August 1, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Disease Progression
• HIV Disease Progression
• HIV Infections

Intervention

Drug:
• Azithromycin Oral Tablet
Antimicrobial therapy
• Placebo oral tablet
Inert ingredients

Locations

Country	Name	City	State
Botswana	University of Botswana	Gaborone
Congo	Fondation Congolaise pour la Recherche Médicale	Brazzaville
Côte D'Ivoire	Centre de Prise en Charge et de Formation	Abidjan
Côte D'Ivoire	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
Ethiopia	Adama Hospital Medical College	Adama
Ghana	Komfo Anokye Teaching Hospital	Kumasi
Malawi	Lilongwe Medical Relief Fund/UNC Project	Lilongwe
Mozambique	Faculty of Medicine, Eduardo Mondlane University	Maputo
Nigeria	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
Rwanda	Centre Hospitalier Universitaire de Kigali (CHUK)	Kigali
Sierra Leone	College of Medicine and Allied Health Sciences, University of Sierra Leone	Freetown
South Africa	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	Steve Biko Academic Hospital, University of Pretoria	Pretoria
South Africa	Right to Care NPC, Esizayo Division	Randburg
South Africa	The Aurum Institute	Rustenburg
Tanzania	National Institute for Medical Research (NIMR)	Mbeya
Tanzania	Kibong'oto Infectious Diseases Hospital	Moshi
Tanzania	Kilimanjaro Clinical Research Institute	Moshi
Uganda	Mbarara Regional Referral hospital	Mbarara
Zambia	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

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

Botswana,  Congo,  Côte D'Ivoire,  Ethiopia,  Ghana,  Malawi,  Mozambique,  Nigeria,  Rwanda,  Sierra Leone,  South Africa,  Tanzania,  Uganda,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality over the first 24 weeks after randomization	24 weeks after randomization
Secondary	All-cause mortality	All-cause mortality over the first 12 weeks after randomization	12 weeks after randomization
Secondary	Hospitalization	Hospitalization over the first 24 weeks after randomization	24 weeks after randomization
Secondary	Composite of hospitalization or all-cause mortality	Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization	24 weeks after randomization