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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: Completed Phase 3 study, sponsored by Janssen Scientific Affairs.
NCT00855335 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.
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 |
What the finished NCT00855335 record still lists
NCT00855335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT00855335 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00855335's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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