A Phase 3 interventional study of Azithromycin Oral Tablet and Placebo oral tablet in HIV Disease Progression, sponsored by Population Health Research Institute. Recruiting at 52 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Treatment
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
to azithromycin:
i. to azithromycin, erythromycin, or any macrolide antibiotic; or
ii. Personal or family history of -prolongation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Azithromycin tablet
Drug: Azithromycin Oral Tablet
Matching placebo tablet
Drug: Placebo oral tablet
Antimicrobial therapy
Inert ingredients
All-cause mortality
All-cause mortality over the first 24 weeks after randomization
Time frame: 24 weeks after randomization
All-cause mortality
All-cause mortality over the first 12 weeks after randomization
Time frame: 12 weeks after randomization
Hospitalization
Hospitalization over the first 24 weeks after randomization
Time frame: 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
Time frame: 24 weeks after randomization
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Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Nov 2028, 66 months after the start.
Of 31 non-industry phase 3 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 51. This study's planned 66 months is above that.
Counting every sponsor, half of 65 studies reached it within 26 months; a quarter within 19 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Azithromycin
Acquired Immunodeficiency Syndrome →
Population Health Research Institute →