PACTR201910580840196
Other
未知
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 sites22 target enrollmentOctober 2, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iverpool School of Tropical Medicine
- Enrollment
- 22
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<50 copies/mL)
- •CD4 cell count \> 100 cells/mm3
- •Able to provide written consent
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
Outcomes
Primary Outcomes
Not specified
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