Status:
COMPLETED
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
ViiV Healthcare
Makerere University
Conditions:
HIV
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women Rationale: In developing countries many women present with a new HIV diagnosis in late pregnancy, and are at high r...
Detailed Description
Antiretroviral therapy (ART) in pregnancy is able to effectively reduce mother-to-child transmission (MTCT) of HIV. If untreated, the risk of transmission is around 25% (greater with high viral loads)...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- Willing to participate,
- Women age 18 years and above
- Pregnant
- Untreated HIV infection in late pregnancy at ≥28 - 36 weeks gestation
Exclusion
- Received antiretroviral drugs in previous 6 months
- Ever received integrase inhibitors
- Serum haemoglobin \< 8.0 g/dl
- 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)
- eGFR \< 50ml/min
- Active Hepatitis B infection, history or clinical suspicion of unstable liver disease, or subjects with severe liver disease (Class C by Childs-Hugh criteria)
- Severe pre-eclampsia (e.g. HELLP), or other pregnancy related events such as renal or liver abnormalities (e.g. grade 2 or above proteinuria, elevation in serum creatinine (above 2.5 x ULN), total bilirubin ALT or AST)
- Paternal non-consent (where disclosure to male partner has been made)
- Clinical depression or clinical judgement suggests increased risk of suicidality
Key Trial Info
Start Date :
March 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02245022
Start Date
March 14 2017
End Date
December 6 2018
Last Update
September 4 2025
Active Locations (2)
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1
Desmond Tutu HIV Foundation
Cape Town, Western Cape, South Africa
2
Infectious Diseases Institute
Kampala, Uganda