Status:
COMPLETED
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
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
HIV
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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-...
Detailed Description
There are many biological changes that occur during pregnancy, some of which may affect the way HIV medications are absorbed, distributed and removed within the body. Some medications have been used f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00855335
Start Date
April 9 2009
End Date
August 11 2016
Last Update
July 6 2018
Active Locations (17)
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1
Daytona Beach, Florida, United States
2
Jacksonville, Florida, United States
3
Miami, Florida, United States
4
Pensacola, Florida, United States