HIV/AIDS Malaria Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Living with HIV, on efavirenz-based ART regimen for at least 3 months or dolutegravir based ART for at least a month Adult pregnant women (=18 years of age) without any impaired decision-making capacity At or after 22 ± 6 weeks of gestation estimated by ultrasound scan Willing to adhere to scheduled and unscheduled study visit procedures and to attend follow up visits Resident of the study area Willing to deliver at the study hospital and have a maternal plasma, placental and cord blood samples collected at delivery Virologically suppressed (viral load 100 cells/mm3 Able to provide written consent
Exclusion criteria
Exclusion criteria: Haemoglobin value of <8.0 g/dL Multiple pregnancies (i.e. twin/triplets) Severe malformations or non-viable pregnancy observed by ultrasound Known allergy or contraindication to any of the study drugs On other medications that are known to have clinically significant interactions with efavirenz, dolutegravir or piperaquine such as rifampicin. Medical history of comorbidities that can influence the pharmacokinetic parameters of a study drug, such as clinically significant renal, liver or cardiac diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean and geometric mean ratios (90% confidence interval) of piperaquine pharmacokinetic parameters when DP-IPTp is co administered with 50 mg dolutegravir based ART compared to 600 mg efavirenz-based ART | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Ratios (90% confidence interval) of maternal piperaquine concentrations in women living with HIV on 50 mg dolutegravir based ART compared to women not living with HIV (so not on ART) and not on azithromycin, matched for time since last DP dose and body weight and umbilical cord piperaquine concentration ratios in women living with HIV on 50 mg dolutegravir-based ART compared to women not living with HIV (so not on ART);Geometric mean and geometric mean ratios (90% confidence interval) of piperaquine pharmacokinetic parameters of exposure when dolutegravir-based ART is administered alone compared with co-administration with DP-IPTp;Mean maternal and umbilical cord plasma dolutegravir concentrations in women living with HIV on 50 mg dolutegravir-based ART | — |
Countries
Malawi
Contacts
Public ContactKaren Barnes
Professor of Clinical Pharmacology
Outcome results
None listed