Doravirine Dose Optimisation in Pregnancy

Recruiting now · Phase 4

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT05630638

Run by

University of Liverpool

People needed

76

Starts

2023-10-10

Expected to finish

2028-07-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Desmond Tutu Health Foundation — Cape Town, South Africa (enrolling)

Full record on ClinicalTrials.gov

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