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Could a common antibiotic cut deaths in advanced HIV?

NCT ID NCT05580666

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether taking the antibiotic azithromycin can reduce deaths in adults with advanced HIV. Researchers will give either azithromycin or a placebo to 8,000 participants and track who dies over 24 weeks. The goal is to see if this simple, cheap drug can save lives in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Azithromycin (an antibiotic)
What this could lead to
If it works, this could provide a simple, low-cost way to reduce early deaths in people with advanced HIV.
What could go wrong
This is a large phase 3 trial, but azithromycin is an antibiotic, not an antiviral, so it may not reduce HIV-related deaths. Risks include antibiotic resistance and side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 34 Military Hospital

    RECRUITING

    Freetown, Sierra Leone

  • Adama Hospital Medical College

    RECRUITING

    Ādama, Ethiopia

  • Africa Health Research Institute (AHRI)- Hluhluwe Clinic

    NOT_YET_RECRUITING

    Hluhluwe, South Africa

  • Africa Health Research Institute (AHRI)- KwaMsane Clinic

    NOT_YET_RECRUITING

    Mtubatuba, South Africa

  • Africa Health Research Institute (AHRI)- Mpukunyoni Clinic

    NOT_YET_RECRUITING

    Mtubatuba, South Africa

  • Africa Health Research Institute (AHRI)- Mtubatuba Clinic

    NOT_YET_RECRUITING

    Mtubatuba, South Africa

  • Africa Health Research Institute (AHRI)- Nkundusi Clinic

    NOT_YET_RECRUITING

    Hlabisa, South Africa

  • Africa Health Research Institute (AHRI)- Somkhele Clinic

    NOT_YET_RECRUITING

    Mtubatuba, South Africa

  • Aminu Kano Teaching Hospital

    NOT_YET_RECRUITING

    Kano, Nigeria

  • Asella Referral and Teaching Hospital

    RECRUITING

    Āsela, Ethiopia

  • Centre Hospitalier Universitaire de Kigali (CHUK)

    NOT_YET_RECRUITING

    Kigali, Rwanda

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

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

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

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

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

    RECRUITING

    Freetown, Sierra Leone

  • Desmond Tutu Health Foundation

    NOT_YET_RECRUITING

    Cape Town, South Africa

  • Faculty of Medicine, Eduardo Mondlane University

    NOT_YET_RECRUITING

    Maputo, Mozambique

  • Federal Medical Center

    NOT_YET_RECRUITING

    Umuahia, Nigeria

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

    NOT_YET_RECRUITING

    Cape Town, South Africa

  • Jimma University Hospital

    RECRUITING

    Jimma, Ethiopia

  • Jos University Teaching Hospital

    ACTIVE_NOT_RECRUITING

    Jos, Nigeria

  • Kenema Regional Hospital

    RECRUITING

    Kenema, Sierra Leone

  • Koidu Government Hospital

    RECRUITING

    Koidu, Sierra Leone

  • Komfo Anokye Teaching Hospital

    NOT_YET_RECRUITING

    Kumasi, Ghana

  • Kumasi South Hospital

    RECRUITING

    Kumasi, Ghana

  • Lagos University Teaching Hospital

    RECRUITING

    Lago, Nigeria

  • Lilongwe Medical Relief Fund/UNC Project

    NOT_YET_RECRUITING

    Lilongwe, Malawi

  • Livingstone hospital

    RECRUITING

    Port Elizabeth, South Africa

  • MUJHU

    RECRUITING

    Kampala, Uganda

  • Makeni Regional Hospital

    RECRUITING

    Makeni, Sierra Leone

  • Mbarara Regional Referral hospital

    RECRUITING

    Mbarara, Uganda

  • New Somerset Hospital

    RECRUITING

    Cape Town, South Africa

  • Niger Delta University Teaching Hospital

    NOT_YET_RECRUITING

    Yenagoa, Nigeria

  • Right to Care NPC, Esizayo Division

    COMPLETED

    Randburg, South Africa

  • SICRA Kampala

    RECRUITING

    Kampala, Uganda

  • SICRA Lira

    RECRUITING

    Lira, Uganda

  • Steve Biko Academic Hospital, University of Pretoria

    RECRUITING

    Pretoria, South Africa

  • Suntreso Government Hospital

    RECRUITING

    Kumasi, Ghana

  • The Aurum Institute

    NOT_YET_RECRUITING

    Klerksdorp, South Africa

  • The Aurum Institute

    NOT_YET_RECRUITING

    Rustenburg, South Africa

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

    NOT_YET_RECRUITING

    Lusaka, Zambia

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

    NOT_YET_RECRUITING

    Lusaka, Zambia

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

    NOT_YET_RECRUITING

    Lusaka, Zambia

  • Tigray health research institute (THRI)

    NOT_YET_RECRUITING

    Mek'ele, Ethiopia

  • Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre

    RECRUITING

    Cape Town, South Africa

  • Unité de Soins Ambulatoires et de conseils (USAC)

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

  • University College Hospital

    RECRUITING

    Ibadan, Nigeria

  • University of Abuja Teaching Hospital

    NOT_YET_RECRUITING

    Abuja, Nigeria

  • University of Calabar Teaching Hospital

    NOT_YET_RECRUITING

    Calabar, Nigeria

  • University of Nigeria Teaching Hospital

    RECRUITING

    Enugu, Nigeria

  • University of Uyo Teaching Hospital

    ACTIVE_NOT_RECRUITING

    Uyo, Nigeria

  • Usmanu Danfodiyo University Teaching Hos

    ACTIVE_NOT_RECRUITING

    Sokoto, Nigeria

  • Wits Health Consortium (Pty) Ltd

    RECRUITING

    Johannesburg, South Africa

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