Improving Maternal heAlth by Reducing Malaria in African HIV Women

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barcelona Institute for Global Health
• Collaborators: Bernhard Nocht Institute for Tropical Medicine; Centre de Recherche Médicale de Lambaréné; Centro de Investigação em Saúde de Manhiça; Medical University of Vienna; Medicines for Malaria Venture; Universität Tübingen
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• Permanent resident in the study area

• Gestational age at the first antenatal visit ≤ 28 weeks

• HIV seropositive status

• Agreement to deliver in the study site's maternity(ies) wards

Exclusion Criteria:

• Residence outside the study area or planning to move out in the following 10 months from enrolment

• Gestational age at the first antenatal visit > 28 weeks of pregnancy

• Known history of allergy to CTX

• Known history of allergy or contraindications to DHA-PPQ

• Participating in other intervention studies