NCT05630638RecruitingPhase 4
Doravirine Dose Optimisation in Pregnancy
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 14 Sept 2022
- Start date
- 10 Oct 2023
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Liverpool
- Diseases
- HIV
- NCT number
- NCT05630638
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 76
- From 10 Oct 2023 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any cART in preceding 6 months
- 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)
Other illness
- Chronic hepatitis B (HBV) infection with clinical evidence of transaminitis
Lab values
- 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)
- Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption cannot take DOR as the tablet contains lactose monohydrate
Other
- Clinical depression or clinical judgment suggests increased risk of suicidality
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.