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

Primary Purpose

HIV Disease Progression

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azithromycin Oral Tablet
Placebo oral tablet
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Disease Progression focused on measuring Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Documented HIV infection

  3. CD4 count criteria:

    i. CD4 count ≤ 100 cells/mm3 within past 30 days if on ART; 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 2 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)

Sites / Locations

  • College of Medicine and Allied Health Sciences, University of Sierra LeoneRecruiting
  • New Somerset HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Azithromycin 250 mg once daily

Oral matching placebo, once daily

Arm Description

Active Azithromycin tablet

Matching placebo tablet

Outcomes

Primary Outcome Measures

All-cause mortality
All-cause mortality over the first 24 weeks after randomization

Secondary Outcome Measures

All-cause mortality
All-cause mortality over the first 12 weeks after randomization
Hospitalization
Hospitalization over the first 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

Full Information

First Posted
October 11, 2022
Last Updated
May 25, 2023
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05580666
Brief Title
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Acronym
REVIVE
Official Title
Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Disease Progression
Keywords
Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double blinded placebo-controlled randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded placebo-controlled
Allocation
Randomized
Enrollment
8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Azithromycin 250 mg once daily
Arm Type
Experimental
Arm Description
Active Azithromycin tablet
Arm Title
Oral matching placebo, once daily
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablet
Intervention Type
Drug
Intervention Name(s)
Azithromycin Oral Tablet
Intervention Description
Antimicrobial therapy
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Inert ingredients
Primary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality over the first 24 weeks after randomization
Time Frame
24 weeks after randomization
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality over the first 12 weeks after randomization
Time Frame
12 weeks after randomization
Title
Hospitalization
Description
Hospitalization over the first 24 weeks after randomization
Time Frame
24 weeks after randomization
Title
Composite of hospitalization or all-cause mortality
Description
Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization
Time Frame
24 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Documented HIV infection CD4 count criteria: i. CD4 count ≤ 100 cells/mm3 within past 30 days if on ART; 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 2 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
REVIVE Study Coordinator
Phone
905-297-3479
Email
revive@phri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Eikelboom, MBBS, MSc, FRCPC
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Wasserman, MBChB, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Medicine and Allied Health Sciences, University of Sierra Leone
City
Freetown
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Sesay
Facility Name
New Somerset Hospital
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolene Le Roux

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

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