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Recruiting

NCT Number: NCT05580666

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

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

Recruiting

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Key information

Conditions

HIV Disease Progression Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA), Abidjan, Côte d’Ivoire

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin Oral Tablet

Drug

Antimicrobial therapy

Placebo oral tablet

Drug

Inert ingredients

Primary outcomes

  1. All-cause mortality

    Time frame: 24 weeks after randomization

    All-cause mortality over the first 24 weeks after randomization

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 weeks after randomization

    All-cause mortality over the first 12 weeks after randomization

  2. Hospitalization

    Time frame: 24 weeks after randomization

    Hospitalization over the first 24 weeks after randomization

  3. Composite of hospitalization or all-cause mortality

    Time frame: 24 weeks after randomization

    Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

REVIVE Study Coordinator

CONTACT

[email protected]

905-297-3479

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: REVIVE

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Oct 14, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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