A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

Completed · Phase 3

Conditions studied: HIV, HIV Infections, Pregnancy

In brief

The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.

Key facts

Study ID

NCT00855335

Run by

Janssen Scientific Affairs, LLC

People needed

77

Starts

2009-04-09

Expected to finish

2016-08-11

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant females (18-26 weeks of gestation)
• documented HIV-1 infection
• Receiving darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine at the time of study entry
• Willing to remain on darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine as well as a background regimen, for the duration of the study, including 12 weeks postpartum
• Able to comply with the protocol requirements and to provide written informed consent.

You may not qualify if…

• Patients with any currently active acquired immune deficiency syndrome (AIDS) defining illness and AIDS-related opportunistic infection
• Patients using cytokine inhibitors (e.g., thalidomide), anabolic hormones, cytokines (e.g., IL-2, INF), efavirenz, hydroxyurea, oral hypoglycemics, systemic chemotherapy or known teratogenic agent
• Use of an investigational agent within 90 days
• Any known fetal anomaly
• Any current obstetric complication, including multiple gestations and pre-term labor
• Hepatitis B and/or C virus infection
• Grade 2 or higher anemia
• Thyroid disease
• Uncontrolled Diabetes Mellitus Types I and II, or gestational diabetes, as determined by the investigator

Where it is running

• Study site — Daytona Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Dearborn, Michigan, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Bellaire, Texas, United States
• Study site — San Juan Pr, Puerto Rico

Full record on ClinicalTrials.gov

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