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Doravirine Dose Optimisation in Pregnancy

RecruitingPhase 4

Sponsor: University of Liverpool

Conditions: HIV

Interventions: Doravirine, Dolutegravir

Countries: South Africa

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Cape Town, South Africa