A Phase 4 interventional study of Doravirine and Dolutegravir in HIV, sponsored by University of Liverpool. Recruiting at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Liverpool · Phase 4, Interventional, and Treatment
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.
Women diagnosed HIV positive in the second trimester of pregnancy in South Africa will be enrolled and randomised 1:1 to receive standard of care or doravirine plus 2 NRTI backbone. Participants will receive study treatment until delivery and up to 28 weeks postpartum, with a maximum total of 14 months of study treatment. Given the high prevalence of NNRTI resistance, alternative ARV treatment options are essential. Doravirine is licenced for the treatment of HIV-1 in adults in North America and Europe. Whilst the efficacy and safety of doravirine has been established in non-pregnant adults, there are no adequate human data available to establish whether DOR poses a risk to pregnancy outcomes. It is important to have data on the safety and pharmacokinetics of the drug during pregnancy and in particularly the third trimester of pregnancy in order to support its use. The hypothesis for this study is that pregnancy influences the pharmacokinetics of doravirine when initiated in the second trimester.
University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
doravirine/lamivudine/tenofovir disoproxil 100 mg/ 300 mg/ 245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study
Drug: Doravirine
dolutegravir/lamivudine/tenofovir disoproxil 50 mg/300 mg/245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study
Drug: Dolutegravir
Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil
Also known as: Delstrigo
Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil
Also known as: TLD
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 postpartum
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 postpartum
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 postpartum
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 postpartum
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 months
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 postpartum
To assess maternal viral load responses
Viral load assessment
Time frame: Delivery and 6 months postpartum
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 postpartum
To assess the prevalence or emergence of HIV drug resistance by determining HIV mutations
Assessment of drug resistance tests
Time frame: Until study completion, a maximum of 13 months
Viral dynamics in the genital tract of mothers
Assessment of viral load in the genital tract
Time frame: Baseline and 32 to 36 weeks gestation
PK in the genital tract of mothers
Assessment of drug concentrations in the genital tract
Time frame: Baseline and 32 to 36 weeks gestation
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 postpartum
Prevalence or emergence of HIV drug resistance by determining HIV mutations
Assessment of drug resistance tests
Time frame: Baseline to 24 weeks postpartum
Plan to share: Yes — The investigators will consider all reasonable requests by health-care providers, investigators, and researchers to provide anonymised data to address specific scientific or clinical objectives. The investigators are committed to reviewing requests from researchers for access to clinical trial protocols, de-identified patient-level clinical trial data, and study-level clinical trial data. Data will be assigned a DOI through deposition in the University of Liverpool Research Data Catalogue (rdm@liverpool.ac.uk) and shared under a Data Transfer agreement (or equivalent e.g. as part of a research collaboration agreement or confidentiality disclosure agreement).
Supporting information: Study protocol
Time frame: After study analysis has completed and manuscript is published for at least 5 years afterwards.
Access criteria: By reasonable request to the investigators.
No publications or documents are linked to this record.
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Studies of the drug tested here: Doravirine
University of Liverpool