Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women

EDCTP- RIA2016MC-1613

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.

2019-09-18

2022-07-19

2023-06-19

Completed

Early phase I

666

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Superiority clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blind placebo-controlled', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 666, 'type': 'ACTUAL'}}

2023-07-19