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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Doravirine
DrugFixed dose combination of doravirine, lamivudine and tenofovir disoproxil
Dolutegravir
DrugFixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: DelstrigoExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
AUC of doravirine in pregnant women
Pharmacokinetic parameters of doravirine in pregnancy - AUC
Time frame
24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartum2
Cmax of doravirine in pregnant women
Pharmacokinetic parameters of doravirine in pregnancy - Cmax
Time frame
24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartum3
Cmin of doravirine in pregnant women
Pharmacokinetic parameters of doravirine in pregnancy - Cmin
Time frame
24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartum4
CL/F of doravirine in pregnant women
Pharmacokinetic parameters of doravirine in pregnancy - CL/F
Time frame
24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartumSecondary outcomes
1
To assess the number of treatment related adverse events by DAIDS v2.1
Safety and tolerability of doravirine in mothers and neonates
Time frame
Until study completion, a maximum of 13 months2
To determine the concentration of doravirine in breastmilk, in breastfed infants, in genital tract, cord blood
Pharmacokinetics of doravirine in various compartments
Time frame
24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartum3
To assess maternal viral load responses
Viral load assessment
Time frame
Delivery and 6 months postpartum4
To determine infant transmissions in the first 6 months of life using HIV viral load
Assessment of perinatal transmission using HIV viral load
Time frame
Delivery until 6 months postpartumOther outcomes
1
Viral dynamics in the genital tract of mothers
Assessment of viral load in the genital tract
Time frame
Baseline and 32 to 36 weeks gestation2
PK in the genital tract of mothers
Assessment of drug concentrations in the genital tract
Time frame
Baseline and 32 to 36 weeks gestation3
PK of DOR in breastmilk, breastfed infants and in the genital tract
Assessment of drug concentrations in non-plasma compartments
Time frame
Delivery, 6 weeks postpartum and 24 weeks postpartum4
Prevalence or emergence of HIV drug resistance by determining HIV mutations
Assessment of drug resistance tests
Time frame
Baseline to 24 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Liverpool
Lead sponsor
Liverpool School of Tropical Medicine
Collaborator
Desmond Tutu Health Foundation
Collaborator
Source ClinicalTrials.gov