Doravirine Dose Optimisation in Pregnancy
ConditionHIV
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Liverpool
About this trial
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.
Eligibility criteria
Qualifiers
Women ≥ 18 years old
Ability to give informed consent prior to participation
Willing and able to comply with all study requirements
HIV positive
Disqualifiers
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
Trial design
Treatments tested in this trial
- Doravirine
- Dolutegravir
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Liverpool
Lead sponsor
Liverpool School of Tropical Medicine
Collaborator
Desmond Tutu Health Foundation
Collaborator
Source ClinicalTrials.gov