Status:
COMPLETED
Dolutegravir in Pregnant HIV Mothers and Their Neonates
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
UNITAID
University of Cape Town
Conditions:
HIV-1-infection
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women...
Detailed Description
This is an open-label, randomised controlled trial of DTG versus EFV -based regimens for 250 women commencing cART in late pregnancy, randomised 1:1 to DTG vs EFV-based cART. The purpose of this study...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women aged 18 years or older
- Pregnant ( ≥28 weeks gestation by best available gestation estimation)
- Untreated HIV infection in late pregnancy
Exclusion
- Received any antiretroviral drugs in previous 12 months
- Ever received integrase inhibitors
- Previous documented failure of an NNRTI-containing ART regimen, previous EFV-associated toxicity or other history of ARV use that would preclude randomisation based on investigator judgement
- Serum haemoglobin \<8.0 g/dl
- eGFR\<50 ml/min\*
- 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).
- History or clinical suspicion of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hyperbilirubinaemia, oesophageal or gastric varices or persistent jaundice).
- Severe pre-eclampsia (e.g. HELLP), or other pregnancy related events such as renal or liver abnormalities (e.g. grade 2 or above proteinuria,, total bilirubin, ALT or AST)\* at the time of enrolment
- Paternal objection for infant participation in DTG arm (where disclosure has taken - applies to Uganda site only
- Medical, psychiatric or obstetric condition that might affect participation in the study based on investigator judgement
- Receiving any of the following medications (current or within past 2 weeks): anti-epileptic drugs, TB therapy, or other drugs known to significantly interact with either DTG or EFV
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT03249181
Start Date
January 22 2018
End Date
September 5 2023
Last Update
February 21 2025
Active Locations (2)
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1
University of Cape Town
Cape Town, Western Cape, South Africa
2
Infectious Diseases Institute
Kampala, Uganda