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Doravirine Dose Optimisation in Pregnancy — DoraDO  

HIV Clinical Trial

Official title:
Doravirine Dose Optimisation in Pregnancy

Clinical Trial Summary

A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.

Clinical Trial Description

Women diagnosed HIV positive in the second trimester of pregnancy in South Africa will be enrolled and randomised 1:1 to receive standard of care or doravirine plus 2 NRTI backbone. Participants will receive study treatment until delivery and up to 28 weeks postpartum, with a maximum total of 14 months of study treatment. Given the high prevalence of NNRTI resistance, alternative ARV treatment options are essential. Doravirine is licenced for the treatment of HIV-1 in adults in North America and Europe. Whilst the efficacy and safety of doravirine has been established in non-pregnant adults, there are no adequate human data available to establish whether DOR poses a risk to pregnancy outcomes. It is important to have data on the safety and pharmacokinetics of the drug during pregnancy and in particularly the third trimester of pregnancy in order to support its use. The hypothesis for this study is that pregnancy influences the pharmacokinetics of doravirine when initiated in the second trimester. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05630638
Study type Interventional
Source University of Liverpool
Contact Helen Reynolds
Phone + 44 151 794 5553
Email dorado@liverpool.ac.uk
Status Recruiting
Phase Phase 4
Start date October 10, 2023
Completion date February 2026
View Details
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