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NCT03431168 · ClinicalTrials.gov registry record · Phase 2
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
NCT03431168: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT03431168 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 308 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03431168, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
Study 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.
Primary Outcome
P. falciparum detected by microscopy or polymerase chain reaction (PCR)
Interventions
- DRUG Azithromycin/TMPS
- DRUG Placebo/TMPS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2022-01-01 |
| Phase | Phase 2 |
What the finished NCT03431168 record still lists
NCT03431168 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 2 interventions - of which Azithromycin/TMPS is the first listed.
NCT03431168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03431168 about?
NCT03431168 is a clinical study titled "A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV". 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...
What is the current status of trial NCT03431168?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2018-03-07. Estimated completion is 2022-01-01.
What interventions are being tested in trial NCT03431168?
The interventions under investigation include: Azithromycin/TMPS (DRUG), Placebo/TMPS (DRUG).
Who is sponsoring clinical trial NCT03431168?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03431168's enrollment target sits among peer trials
308 163rd of 2000 higher than 1,836 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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