Doravirine Dose Optimisation in Pregnancy
Recruiting · NCT05630638 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Liverpool
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Desmond Tutu Health Foundation - Cape Town, South Africa