Optimizing doravirine dosing for pregnant women with HIV
Doravirine Dose Optimisation in Pregnancy
This study is testing if a new HIV medication called doravirine is safe and effective for pregnant women during their second trimester to help improve treatment options for them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Liverpool Academic / other |
| Drugs / interventions | cART |
| Locations | 1 site (Cape Town) |
| Trial ID | NCT05630638 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include HIV-positive women aged 18 and older who are in their second trimester of pregnancy and intend to breastfeed postpartum.
Not a fit: Patients who have received combination antiretroviral therapy in the past six months or have chronic hepatitis B infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer and more effective treatment options for pregnant women living with HIV.
How similar studies have performed: While doravirine has been established as effective in non-pregnant adults, this study is novel as it specifically addresses its use and safety in pregnant women.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cape Town
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.