Malaria
Conditions
Interventions
sulfamethoxazole trimethoprim and dihydroartemisinin piperaquine
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: HIV-infected pregnant women between 16-28 weeks' gestation Viable singleton pregnancy On or eligible for cARTs and CTX A resident of the study area Willing to adhere to scheduled and unscheduled study visit procedures Willing to deliver in a study clinic or hospital Provide written informed consen
Exclusion criteria
Exclusion criteria: Multiple pregnancies (i.e. twin/triplets) HIV-negative or HIV status unknown Known heart ailment Severe malformations or non-viable pregnancy if observed by ultrasound Participants with advanced HIV-disease at WHO clinical stage 3 and 4 Confirmed or suspected TB infection, Unable to give consent Known allergy or contraindication to any of the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of malaria infection [ Time Frame: Detected from 2 weeks after the first day of the first dose of the first course to delivery inclusive. The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months. ] The primary outcome will be the cumulative incidence of malaria infection detected from 2 weeks after the first day of the first dose of the first course to delivery inclusive, defined as the presence of peripheral (maternal) or placental (maternal) Plasmodium infection detected by either molecular diagnostics (henceforth referred to as PCR), microscopy, RDT or placental histology (active infection). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Cardiac safety, serious adverse events and MTCT of HIV [ Time Frame: The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months (12 months recruitment plus 7 months of mother-infant follow-up until the child is 6 weeks old ] QTc-prolongation. Congenital malformations. Maternal mortality Other SAEs and AEs. Mother to child transmission of HIV ;Tolerance [ Time Frame: The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months (12 months recruitment plus 7 months of mother-infant follow-up until the child is 6 weeks old ] History of vomiting study drug (<30 min). Dizziness. Gastrointestinal complaints. ;Antimicrobial activity and resistance [ Time Frame: The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months (12 months recruitment plus 7 months of mother-infant follow-up until the child is 6 weeks old ] Frequency of molecular markers of drug resistance in Plasmodium falciparum infections during pregnancy and delivery;Pharmacokinetic parameters [ Time Frame: The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months (12 months recruitment plus 7 months of mother-infant follow-up until the child is 6 weeks old ] Standard pharmacokinetic parameters for dolutegravir, piperaquine and CTX.;Efficacy of the intervention on the following listed secondary outcomes [ Time Frame: The total duration of the trial is 24 months. Actual participant recruitment and follow up is expected to take up to 19 months (12 months recruitment plus 7 months of mother-infant follow-up until the child is 6 weeks old ] Incidence of malaria infection The individual components of the composite malaria infection endpoints Incidence of clinical malaria. Malari | — |
Countries
Kenya
Contacts
Public ContactHellen Barsosio
Senior Research Officer
Outcome results
None listed