Actively Recruiting
Doravirine Dose Optimisation in Pregnancy
Led by University of Liverpool · Updated on 2026-02-19
76
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
U
University of Liverpool
Lead Sponsor
L
Liverpool School of Tropical Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Doravirine Dose Optimisation in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years or older
- Able to give informed consent before joining the study
- Willing and able to follow all study procedures
- Diagnosed with HIV
- Pregnant, starting combination antiretroviral therapy (cART) at or after 12 weeks but before 26 weeks of pregnancy
- Plan to breastfeed after delivery
You will not qualify if you...
- Received any combination antiretroviral therapy (cART) in the past 6 months
- Have chronic hepatitis B infection with signs of liver inflammation
- Have very high liver enzyme levels (ALT above 5 times the normal limit or ALT above 3 times normal with bilirubin over 2 times normal and more than 35% direct bilirubin)
- Previously failed treatment with an NNRTI-containing cART regimen
- Known allergy to any antiretroviral drug
- Taking medications that strongly affect metabolism of study drugs such as rifampicin, anti-epileptic drugs, rifabutin, St John's Wort, mitotane, enzalutamide, or lumacaftor
- Have rare inherited conditions like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- Have clinical depression or are considered at increased risk of suicide by a doctor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Desmond Tutu Health Foundation
Cape Town, South Africa
Actively Recruiting
Research Team
H
Helen Reynolds
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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