RecruitingPhase 4NCT05630638
Doravirine Dose Optimisation in Pregnancy
Sponsor
University of Liverpool
Enrollment
76 participants
Start Date
Oct 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
DRUGDoravirine
Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil
DRUGDolutegravir
Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05630638
Related Trials
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
NCT071993352 locations
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
NCT054190241 location
LA PrEP Impact and Cost-effectiveness (TEAMS)
NCT0577454812 locations
Incidence of Liver Disease-Related Outcomes in People With HIV
NCT069403752 locations
Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
NCT001146471 location