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
Public ClinicalTrials.gov record NCT00855335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00855335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Interventions
- Darunavir Drug
- Ritonavir Drug
- Etravirine Drug
- Rilpivirine Drug
- Darunavir/Cobicistat (FDC) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 8, 2009
- Primary completion
- Aug 10, 2016
- Completion
- Aug 10, 2016
- Last update posted
- Jul 5, 2018
2009 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Daytona Beach | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Pensacola | Florida | — | — |
| Not listed | Port Saint Lucie | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Savannah | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Springfield | Massachusetts | — | — |
| Not listed | Dearborn | Michigan | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Greensboro | North Carolina | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Bellaire | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00855335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2018 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00855335 live on ClinicalTrials.gov.