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
Summary
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.
Timeline
- Start
- 2009-04-09
- Primary completion
- 2016-08-11
- Completion
- 2016-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Subject | Darunavir | Small molecule | 600 mg | Oral |
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | Oral |
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |