HIV Disease ProgressionPhase 3REVIVENCT05580666
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
A Phase 3 study testing Azithromycin Oral Tablet in people with HIV Disease Progression, run by Population Health Research Institute at 52 sites in 11 countries.
Trial summary
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Disease Progression
- What is being tested?
- Azithromycin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,000 participants
- Where
- 52 sitesin 11 countries
- Study dates
- 8 May 2023to 31 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Documented HIV infection
- CD4 count criteria:
- CD4 count ≤ 100 cells/mm3 within past 4 weeks; or
- Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or
- 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
Who cannot join
- Contraindications to azithromycin:
- Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or
- 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
Trial locations and contacts
52 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 11 countries
South Africa16 sites, 15 recruiting
- Not yet recruiting
Desmond Tutu Health Foundation
Cape Town
Chantel Schreuder
- Not yet recruiting
Groote Schuur Hospital -New main building, Infectious Disease Clinic G26
Cape Town
Phiona Namale
- Recruiting
New Somerset Hospital
Cape Town
Nicolene Le Roux
- Recruiting
Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre
Cape Town
Leigh Wagner
- Not yet recruiting
Africa Health Research Institute (AHRI)- Nkundusi Clinic
Hlabisa
Lucica D Thaver
- Not yet recruiting
Africa Health Research Institute (AHRI)- Hluhluwe Clinic
Hluhluwe
Alungile N Fileyo
- Recruiting
Wits Health Consortium (Pty) Ltd
Johannesburg
Tom Boyles
- Not yet recruiting
The Aurum Institute
Klerksdorp
James C Innes
- Not yet recruiting
Africa Health Research Institute (AHRI)- KwaMsane Clinic
Mtubatuba
Alungile N Fileyo
- Not yet recruiting
Africa Health Research Institute (AHRI)- Mpukunyoni Clinic
Mtubatuba
Sune Liebetrau
- Not yet recruiting
Africa Health Research Institute (AHRI)- Mtubatuba Clinic
Mtubatuba
Lucica D Thaver
- Not yet recruiting
Africa Health Research Institute (AHRI)- Somkhele Clinic
Mtubatuba
Ngcebo Mhlongo
- Recruiting
Livingstone hospital
Port Elizabeth
Denise Kyazze, denkyaz@gmail.com
- Recruiting
Steve Biko Academic Hospital, University of Pretoria
Pretoria
Veronica Ueckermann
- Completed
Right to Care NPC, Esizayo Division
Randburg
- Not yet recruiting
The Aurum Institute
Rustenburg
William L Brumskine
Nigeria11 sites, 8 recruiting
- Not yet recruiting
University of Abuja Teaching Hospital
Abuja
Vivian Kwaghe
- Not yet recruiting
University of Calabar Teaching Hospital
Calabar
Bassey Ekeng
- Recruiting
University of Nigeria Teaching Hospital
Enugu
Uchechukwu Unigwe
- Recruiting
University College Hospital
Ibadan
Olukemi Adekanmbi
- Active, not recruiting
Jos University Teaching Hospital
Jos
- Not yet recruiting
Aminu Kano Teaching Hospital
Kano
Garba Iliyasu
- Recruiting
Lagos University Teaching Hospital
Lago
Lorhen Akase
- Active, not recruiting
Usmanu Danfodiyo University Teaching Hos
Sokoto
- Not yet recruiting
Federal Medical Center
Umuahia
Chiedozie Maduka
- Active, not recruiting
University of Uyo Teaching Hospital
Uyo
- Not yet recruiting
Niger Delta University Teaching Hospital
Yenagoa
Dimie Ogoina
Sierra Leone5 sites, 5 recruiting
- Recruiting
34 Military Hospital
Freetown
Stephen Sevalie, stevesyllo@gmail.com
- Recruiting
College of Medicine and Allied Health Sciences, University of Sierra Leone
Freetown
Daniel Sesay
- Recruiting
Kenema Regional Hospital
Kenema
Abdulai T Jalloh, abdulaitjalloh@gmail.com
- Recruiting
Koidu Government Hospital
Koidu
Mohamed I Marah, mmarah@pih.org
- Recruiting
Makeni Regional Hospital
Makeni
Matilda Kamara, kamaramatilda9198@gmail.com
Ethiopia4 sites, 4 recruiting
- Recruiting
Adama Hospital Medical College
Ādama
Endashaw A Debela, endashawabebe21@gmail.com
- Recruiting
Asella Referral and Teaching Hospital
Āsela
Gadisa D Ejeta, gadisa600@gmail.com
- Recruiting
Jimma University Hospital
Jimma
Esayas K Gudina, esayas.gudina@ju.edu.et
- Not yet recruiting
Tigray health research institute (THRI)
Mek'ele
Hayelom Bayrau, hayelomk21@gmail.com
Uganda4 sites, 4 recruiting
- Recruiting
MUJHU
Kampala
Brenda C Kakayi, bkakayi@mujhu.org
- Recruiting
SICRA Kampala
Kampala
Lydia Nakiyingi, lydiakiyingi@gmail.com
- Recruiting
SICRA Lira
Lira
Francis Kiweewa, fkiweewa@sicra.org
- Recruiting
Mbarara Regional Referral hospital
Mbarara
Keneth Kananura
Côte d’Ivoire3 sites, 3 recruiting
- Not yet recruiting
Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)
Abidjan
Henri Chenal
- Not yet recruiting
Centre médical de suivi des donneurs de sang (CMSDS)
Abidjan
Albert Minga
- Not yet recruiting
Unité de Soins Ambulatoires et de conseils (USAC)
Abidjan
Serge Koule
Ghana3 sites, 3 recruiting
- Not yet recruiting
Komfo Anokye Teaching Hospital
Kumasi
Yasmine Hardy
- Recruiting
Kumasi South Hospital
Kumasi
Daniel O Minkah, daminkah@yahoo.co.uk
- Recruiting
Suntreso Government Hospital
Kumasi
Sheila Bawa, aposuad@yahoo.com
Zambia3 sites, 3 recruiting
- Not yet recruiting
The Center for Infectious Disease Research in Zambia (CIDRZ)- George Clinical Research Site
Lusaka
Masuzyo Chrwa
- Not yet recruiting
The Center for Infectious Disease Research in Zambia (CIDRZ)- Matero Clinical Research Site
Lusaka
Ethel Kamuti
- Not yet recruiting
The Center for Infectious Disease Research in Zambia (CIDRZ)-Chawama Clinical Research Site (CRS)
Lusaka
Katanekwa Njekwa
Malawi1 site, 1 recruiting
- Not yet recruiting
Lilongwe Medical Relief Fund/UNC Project
Lilongwe
Cecilia Kanyama
Mozambique1 site, 1 recruiting
- Not yet recruiting
Faculty of Medicine, Eduardo Mondlane University
Maputo
Albertino Damasceno
Rwanda1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Kigali (CHUK)
Kigali
Leopold Bitunguhari
About this study
Official title: Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Read the detailed 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.
- Conditions
- HIV Disease Progression
- Being tested
- Azithromycin Oral Tablet, Placebo oral tablet
- Keywords
- Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Oral TabletDrug
Antimicrobial therapy
Placebo oral tabletDrug
Inert ingredients
| Study group | Role | What they receive |
|---|---|---|
| Oral Azithromycin 250 mg once daily | Experimental | Active Azithromycin tablet Receives: Drug: Azithromycin Oral Tablet |
| Oral matching placebo, once daily | Placebo comparator | Matching placebo tablet Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality over the first 24 weeks after randomization
Measured: 24 weeks after randomization
Secondary outcomes (3)
All-cause mortality
All-cause mortality over the first 12 weeks after randomization
Measured: 12 weeks after randomization
Hospitalization
Hospitalization over the first 24 weeks after randomization
Measured: 24 weeks after randomization
Composite of hospitalization or all-cause mortality
Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization
Measured: 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start8 May 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Disease ProgressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded placebo-controlled randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Eikelboom, MBBS, MSc, FRCPC, Principal investigator, Population Health Research InstituteSean Wasserman, MBChB, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580666
- Sponsor's protocol ID
- PHRI.REVIVE
- Acronym
- REVIVE
- Status last verified
- Aug 2025
- First submitted
- 11 Oct 2022
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT05580666
- Acronym / sponsor ID
- REVIVE / PHRI.REVIVE
- Conditions
- HIV Disease Progression
- Keywords
- Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Oral Azithromycin 250 mg once daily | Experimental | Drug: Azithromycin Oral TabletActive Azithromycin tablet |
| Oral matching placebo, once daily | Placebo comparator | Drug: Placebo oral tabletMatching placebo tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Documented HIV infection
- CD4 count criteria:
- Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment
Key exclusion criteria (5 listed)
- Contraindications to azithromycin:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Oral TabletAntimicrobial therapy | Drug | Oral Azithromycin 250 mg once daily |
| Placebo oral tabletInert ingredients | Drug | Oral matching placebo, once daily |
Primary outcome
All-cause mortality
Time frame: 24 weeks after randomization
All-cause mortality over the first 24 weeks after randomization
3 secondary outcomes
All-cause mortality
Time frame: 12 weeks after randomization
Hospitalization
Time frame: 24 weeks after randomization
Composite of hospitalization or all-cause mortality
Time frame: 24 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Eikelboom, MBBS, MSc, FRCPC principal investigator
Population Health Research Institute
Sean Wasserman, MBChB, PhD principal investigator
University of Cape Town
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin Oral Tablet in people with HIV Disease Progression, run by Population Health Research Institute at 52 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in South Africa, Nigeria, Sierra Leone, Ethiopia, Uganda and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact REVIVE Study Coordinator (905-297-3479, revive@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 24 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.