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
Information source: Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; HIV Infections; Pregnancy
Intervention: Darunavir (Drug); Ritonavir (Drug); Etravirine (Drug); Rilpivirine (Drug); Darunavir/Cobicistat (FDC) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC
Overall contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir (darunavir/r), darunavir/cobicistat, etravirine and rilpivirine during the second and third trimesters of gestation, as well as postpartum
Secondary outcome: Changes in anti-viral activity, safety and tolerability antiretroviral regimens during gestation and postpartum; compare concentrations between serum and cord blood; pregnancy outcome of darunavir/r and/or etravirine and rilpivirine
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 for HIV treatment during pregnancy, but little is known about how pregnancy
affects the class of drugs being used in this study. To participate in this study, patients
must be receiving 600mg of TMC114 (darunavir) taken with 100mg ritonavir twice daily or
800mg of TMC114 (darunavir) with 100mg of ritonavir once daily or 800 mg of darunavir taken
with 150mg of cobicistat taken once daily or 200mg of TMC125 (etravirine) (with or without
darunavir/ ritonavir) taken twice daily or 25mg of TMC278 (rilpivirine) taken once daily
plus additional antiretroviral drugs needed to construct an active antiretroviral regimen.
Darunavir and ritonavir, darunavir and cobicistat, etravirine, or rilpivirine will be
supplied to study participants. Darunavir and ritonavir are human immunodeficiency virus
(HIV) protease inhibitors (PIs); cobicistat is a pharmacoenhancer which boosts the levels of
darunavir but has no anti-HIV activity; etravirine and rilpivirine are non-nucleoside
reverse transcriptase inhibitor (NNRTI) of HIV. Twelve-hour or twenty four-hour blood
sampling will be done for each patient at each of three study visits: Visit 4 (2nd
trimester), Visit 5 (3rd trimester), and Visit 8 (6-12 weeks postpartum). Eight blood draws
will be taken during each visit: One prior to intake of study medication, and one for each
of seven post-dose sampling time-points (hours 1, 2, 3, 4, 6, 9 and 12). The study is
designed primarily to examine the pharmacokinetics of darunavir/ritonavir (darunavir/r),
darunavir/ cobicistat, etravirine or rilpivirine during the second and third trimesters of
gestation, as well as postpartum. Pharmacokinetics measures how the body absorbs,
distributes and excretes medication. The study will also examine any changes in anti-viral
activity during pregnancy, and the postpartum period. It will note any safety and
tolerability of the medications used by the mother, and will measure the level of
darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine in the newborn's cord
blood at the time of delivery; outcomes for both mother and child will be assessed as well.
During the treatment period, patients will be seen at regular visits in the clinic, where
the investigator will assess the patient's medical condition, any Adverse Events and study
drug compliance. Laboratory evaluations for efficacy and safety will be done at regular
visits as well as blood pressure monitoring. Up to forty-eight (48) HIV positive pregnant
women will participate in this study. Study enrollment will be closed once 12 evaluable
patients taking darunavir/ritonavir once daily, 12 evaluable patients taking
darunavir/cobicistat once daily, 12 evaluable patients taking darunavir/ritonavir twice
daily, 12 evaluable patients taking etravirine taking twice daily and 12 evaluable patients
taking rilpivirine once daily have been enrolled. The study will be conducted at
approximately 14 research centers in the United States and 1 in Puerto Rico. In order to
participate, patients must be pregnant for 13-24 weeks. The primary purpose (or outcome) of
the study is to assess the influence of pregnancy on the pharmacokinetics of
darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine during the second and
third trimesters of gestation, as well as postpartum. Darunavir: One 600 mg or two 300 mg
tablets taken twice daily by mouth (two or four tablets a day total). Ritonavir: 100mg
tablet taken twice daily by mouth (two tablets a day total), together with darunavir.
Darunavir: Two 400 mg tablets taken once daily by mouth (two tablets a day total).
Ritonavir: 100mg tablet taken once daily by mouth (one tablet a day total), together with
darunavir. Darunavir/ cobicistat: a fixed dose combination containing 800mg of darunavir and
150mg of cobicistat. Etravirine: Two 100 mg tablets taken twice daily by mouth (four tablets
a day total). Rilpivirine: One 25mg tablet taken once daily by mouth (one tablet a day
total). Study medication will be given from the baseline visit (second pregnancy trimester)
until Visit 8 (up to 12 weeks after delivery).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
- Diabetes, including gestational diabetes.
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
San Juan Pr, Puerto Rico; Recruiting
Aurora, Colorado, United States; Withdrawn
Daytona Beach, Florida, United States; Recruiting
Jacksonville, Florida, United States; Completed
Miami, Florida, United States; Recruiting
Pensacola, Florida, United States; Completed
Port Saint Lucie, Florida, United States; Completed
West Palm Beach, Florida, United States; Recruiting
Savannah, Georgia, United States; Not yet recruiting
Chicago, Illinois, United States; Not yet recruiting
Springfield, Massachusetts, United States; Completed
Dearborn, Michigan, United States; Completed
Bronx, New York, United States; Recruiting
Bronx, New York, United States; Completed
Chapel Hill, North Carolina, United States; Completed
Greensboro, North Carolina, United States; Recruiting
Philadelphia, Pennsylvania, United States; Completed
Bellaire, Texas, United States; Recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: April 2009
Last updated: August 20, 2015
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