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Reducing Mortality in Adults With Advanced HIV Disease (REVIVE) (REVIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05580666
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

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

Condition or disease Intervention/treatment Phase
HIV Disease Progression Drug: Azithromycin Oral Tablet Drug: Placebo oral tablet Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded placebo-controlled randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded placebo-controlled
Primary Purpose: Treatment
Official Title: Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
Actual Study Start Date : May 8, 2023
Estimated Primary Completion Date : May 31, 2028
Estimated Study Completion Date : August 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Azithromycin 250 mg once daily
Active Azithromycin tablet
 Drug: Azithromycin Oral Tablet
Antimicrobial therapy
Placebo Comparator: Oral matching placebo, once daily
Matching placebo tablet
 Drug: Placebo oral tablet
Inert ingredients


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 24 weeks after randomization ]
    All-cause mortality over the first 24 weeks after randomization


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05580666


Contacts
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Contact: REVIVE Study Coordinator 905-297-3479 revive@phri.ca

Locations
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Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: John Eikelboom, MBBS, MSc, FRCPC Population Health Research Institute
Principal Investigator: Sean Wasserman, MBChB, PhD University of Cape Town
More Information
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT05580666    
Other Study ID Numbers: PHRI.REVIVE
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Human immunodeficiency virus
Antiretroviral therapy
Azithromycin
Mortality
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Disease Progression
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents