NCT02075593

ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection

ING200336: A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections
• Arthralgia

Interventions

Type	Name	Description
DRUG	DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets	The DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablet is a purple, oval, biconvex tablets. The tablet contains 52.6 mg DTG sodium which is equivalent to 50 mg DTG free acid, 702 mg ABC sulphate which is equivalent to 600 mg ABC and 300 mg 3TC.

Timeline

• Start date: 2014-12-17
• Primary completion: 2018-10-22
• Completion: 2021-09-15
• First posted: 2014-03-03
• Last updated: 2022-10-06
• Results posted: 2022-02-18

Locations

3 sites across 2 countries: Russia, Spain