Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 14, 2017

Primary Completion Date

December 6, 2018

Study Completion Date

December 6, 2018

Conditions
HIVPregnancy
Interventions
DRUG

Dolutegravir 50mg od

Patients randomised to receive either Dolutegravir 50mg od or standard of care (Efavirenz 600mg od) plus Lamivudine 300mg od/ Tenofovir 300mg od

DRUG

Standard of Care

Patients are randomised 1:1 to receive either Dolutegravir 50mg once daily in combination with Lamivudine 300mg od and tenofovir 300mg od or standard of care (Efavirenz 600mg plus Lamivudine 300mg od and tenofovir 300mg od)

Trial Locations (2)

Unknown

Desmond Tutu HIV Foundation, Cape Town

Infectious Diseases Institute, Kampala

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

collaborator

Makerere University

OTHER

lead

University of Liverpool

OTHER

NCT02245022 - Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study | Biotech Hunter | Biotech Hunter