NCT05630638

Doravirine Dose Optimisation in Pregnancy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: University of Liverpool · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Doravirine	Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil
DRUG	Dolutegravir	Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil

Timeline

• Start date: 2023-10-10
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2022-11-29
• Last updated: 2026-02-19

Locations

1 site across 1 country: South Africa