MedTrace Logo

Improving Maternal heAlth by Reducing Malaria in African HIV Women

NCT03671109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2024-10-01

No results posted yet for this study

Summary

Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.

Conditions

Interventions

DRUG

Dihydroartemisinin-piperaquine (DHA-PPQ)

Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision

DRUG

Placebo Oral Tablet

Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Universität Tübingen

    collaborator OTHER

  • Centre de Recherche Médicale de Lambaréné

    collaborator OTHER

  • Medical University of Vienna

    collaborator OTHER

  • Bernhard Nocht Institute for Tropical Medicine

    collaborator OTHER_GOV

  • Centro de Investigação em Saúde de Manhiça

    collaborator OTHER

  • Barcelona Institute for Global Health

    lead OTHER

Principal Investigators

  • Clara Menendez, MD, PhD · Barcelona Institute for Global Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2022-07-19
Completion
2023-06-19

Countries

  • Gabon
  • Mozambique

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 NCT03671109 on ClinicalTrials.gov