CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 308 enrolled
Drug / intervention
Azithromycin/TMPS +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03431168
NCT03431168Phase 2Completed
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The PREMISE Trial: A Novel Regimen to Prevent Malaria and Sexually Transmitted Infections in Pregnant Women With HIV

University of Alabama at Birmingham·interventional·Posted Feb 13, 2018·Updated Nov 27, 2023

In Brief

A Phase 2 clinical trial evaluating Azithromycin/TMPS and Placebo/TMPS for HIV and 2 related conditions. Completed, enrolled 308 participants across 1 site.

Detailed Summary

More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Pregnancy Malaria, Sexually Transmitted Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 13, 2018
Enrollment StartMar 7, 2018
Primary CompletionJan 1, 2021
Study CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.4 years ago

Interventions

Azithromycin/TMPSdrug

2 tabs po daily x 3 days at enrollment and at each monthly follow up visit

Placebo/TMPSdrug

2 tabs po daily x 3 days at enrollment and at each monthly follow up visit