Doravirine Dose Optimisation in Pregnancy

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liverpool
• Collaborators: Desmond Tutu Health Foundation; Liverpool School of Tropical Medicine
• Treatments: Dolutegravir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Received any cART in preceding 6 months

• Chronic hepatitis B (HBV) infection with clinical evidence of transaminitis

• Elevations in serum levels of alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN) or ALT > 3xULN and bilirubin >2xULN (with > 35 % direct bilirubin)

• Previous documented failure of an NNRTI-containing cART regimen

• Previous history of hypersensitivity to any ARV

• Concomitant medication which are inducers of SoC and DOR metabolism (e.g. rifampicin, anti-epileptic agents, rifabutin, St John's Wort, mitotane, enzalutamide, lumacaftor). Contraindicated medications can be found on Liverpool Drug Interactions website (hiv-druginteractions.org)

• Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption cannot take DOR as the tablet contains lactose monohydrate

• Clinical depression or clinical judgment suggests increased risk of suicidality