Optimizing doravirine dosing for pregnant women with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the pharmacokinetics and safety of doravirine in pregnant women diagnosed with HIV during their second trimester. Participants will be randomly assigned to receive either standard care or doravirine combined with two nucleoside reverse transcriptase inhibitors until delivery and up to 28 weeks postpartum. The study aims to gather essential data on the effects of pregnancy on doravirine's pharmacokinetics, addressing the need for effective antiretroviral therapy options in this population. The research is conducted in South Africa, where the prevalence of NNRTI resistance is high.

Why it matters

Who can join: the full rules

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

Where it's running

• Desmond Tutu Health Foundation
  Cape Town, South Africa Recruiting

Study contacts

• Principal investigator: Saye Khoo — University of Liverpool
• Study coordinator: Helen Reynolds
• Email: dorado@liverpool.ac.uk
• Phone: + 44 151 794 5553

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.