IMPROVE DDI sub-study: Dihydroartemisinin piperaquine (DP)-Dolutegravir-based ART drug-drug interactions in pregnancy

Not Applicable

• Conditions: HIV/AIDS; Malaria; Pregnancy and Childbirth

• Registration Number: PACTR201910580840196
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified