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NCT00855335 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT00855335 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 77 participants.
The verdict
NCT00855335, a Phase 3 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ritonavir
- DRUG Etravirine
- DRUG Darunavir
- DRUG Rilpivirine
- DRUG Darunavir/Cobicistat (FDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2009-04-09 |
| Est. Completion | 2016-08-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00855335
The ClinicalTrials.gov registry entry for NCT00855335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT00855335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00855335 about?
NCT00855335 is a clinical study titled "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". 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 ...
What is the current status of trial NCT00855335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2009-04-09. Estimated completion is 2016-08-11.
What interventions are being tested in trial NCT00855335?
The interventions under investigation include: Ritonavir (DRUG), Etravirine (DRUG), Darunavir (DRUG), Rilpivirine (DRUG), Darunavir/Cobicistat (FDC) (DRUG).
Who is sponsoring clinical trial NCT00855335?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
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