Impact of dolutegravir-based antiretroviral therapy on the pharmacokinetic profile of piperaquine administered as dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnant women living with human immunodeficiency virus in Malawi: a fixed sequence cohort study

iverpool School of Tropical Medicine0 个研究点目标入组 22 人开始时间: 2019年10月2日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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 <50 copies/mL)
•CD4 cell count > 100 cells/mm3
•Able to provide written consent

•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

发起方

iverpool School of Tropical Medicine