ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
Status:
Completed
Trial end date:
2021-09-15
Target enrollment:
Participant gender:
Summary
In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination
(FDC) tablet is being made available to women who become pregnant while participating in
study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the
unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing the
risk for maternal disease progression), but also to reduce the risk of maternal-fetal
transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study
also offers the first opportunity to investigate the impact of pregnancy on DTG
pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of
women that will be enrolled into this study cannot be established a priori, as unintended
pregnancies cannot be determined in advance. The maximum number of women would include all of
those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended pregnancies
in all of these women would not be anticipated.