HIV Disease Progression
Conditions
Keywords
Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality
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. Total follow up duration will be 48 weeks.
Interventions
Antimicrobial therapy
DRUGPlacebo oral tablet
Inert ingredients
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded placebo-controlled
Intervention model description
Double blinded placebo-controlled randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 24 weeks after randomization | All-cause mortality over the first 24 weeks after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 12 weeks after randomization | All-cause mortality over the first 12 weeks after randomization |
| Hospitalization | 24 weeks after randomization | Hospitalization over the first 24 weeks after randomization |
| Composite of hospitalization or all-cause mortality | 24 weeks after randomization | Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization |
Countries
Côte d’Ivoire, Ethiopia, Ghana, Malawi, Mozambique, Nigeria, Rwanda, Sierra Leone, South Africa, Uganda, Zambia
Contacts
Primary ContactREVIVE Study Coordinator
Outcome results
None listed