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A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV

NCT03431168 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2023-11-27

Study results available
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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.

Conditions

  • HIV
  • Pregnancy Malaria
  • Sexually Transmitted Infection

Interventions

DRUG

Azithromycin/TMPS

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

DRUG

Placebo/TMPS

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jodie A Dionne-Odom, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2021-01-01
Completion
2022-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431168 on ClinicalTrials.gov