Doravirine Dose Optimisation in Pregnancy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Women ≥ 18 years old
• Ability to give informed consent prior to participation
• Willing and able to comply with all study requirements
• HIV positive
• Pregnant (initiating cART ≥ 12 weeks and \< 26 weeks gestation)
• Intention to breastfeed postpartum
Locations
Other Locations
South Africa
Desmond Tutu Health Foundation
RECRUITING
Cape Town
Contact Information
Primary
Helen Reynolds
dorado@liverpool.ac.uk
+ 44 151 794 5553
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-02
Participants
Target number of participants: 76
Treatments
Experimental: Delstrigo
doravirine/lamivudine/tenofovir disoproxil 100 mg/ 300 mg/ 245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study
Active_comparator: Standard of care
dolutegravir/lamivudine/tenofovir disoproxil 50 mg/300 mg/245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study
Related Therapeutic Areas
Sponsors
Leads: University of Liverpool
Collaborators: Liverpool School of Tropical Medicine, Desmond Tutu Health Foundation