Trial record 2 of 170 for:    Darunavir OR Prezista[TREATMENT] AND HIV [CONDITION]

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir/Ritonavir, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00855335
First received: March 2, 2009
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to look at how changes in the body during pregnancy may change the blood levels of TMC114 (darunavir) and ritonavir taken together, TMC125 (etravirine) taken alone or with darunavir and ritonavir and rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will look at 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 and/or 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.


Condition Intervention Phase
HIV
HIV Infections
Pregnancy
Drug: TMC114 (darunavir)
Drug: ritonavir
Drug: TMC125 (etravirine)
Drug: TMC278 (rilpivirine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label Study to Assess the Pharmacokinetics of Darunavir/Ritonavir and/or Etravirine and Rilpivirine in HIV-1 Infected Pregnant Women

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • To assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or etravirine and rilpivirine during the second and third trimesters of gestation, as well as postpartum [ Time Frame: During the second and third trimesters of gestation, as well as postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: During gestation and postpartum. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 002
TMC125 (etravirine) Two 100 mg tablet twice daily up to 12 weeks postpartum
Drug: TMC125 (etravirine)
Two 100 mg tablet
Experimental: 001
TMC114 (darunavir) Two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum / ritonavir one 100 mg tablet twice daily with darunavir up to 12 weeks postpartum
Drug: TMC114 (darunavir)
Two 300 mg or one 600 mg tablet
Drug: ritonavir
100 mg capsules with darunavir
Experimental: 003
TMC114 (darunavir) Two 400 mg tablets once daily up to 12 weeks postpartum / ritonavir one 100 mg tablet once daily with darunavir up to 12 weeks postpartum
Drug: ritonavir
100 mg capsules with darunavir
Drug: TMC114 (darunavir)
Two 400 mg tablets
Experimental: 004
TMC278 (rilpivirine) One 25 mg tablet once daily up to 12 weeks postpartum
Drug: TMC278 (rilpivirine)
One 25 mg tablet

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 looked at in this study. To participate in this study, patients must be receiving 600mg of TMC114 (darunavir) taken with 100mg ritonavir twice daily and/or 200mg of TMC125 (etravirine) twice daily, or 800mg of TMC114 (darunavir) or 25mg of TMC278 (rilpivirine) plus additional antiretroviral drugs needed to construct an active antiretroviral regimen. Darunavir and ritonavir, etravirine, or rilpivirine will be supplied to study participants. Darunavir and ritonavir are human immunodeficiency virus (HIV) protease inhibitors (PIs); 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 look at the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or 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 look for any changes in anti-viral activity during pregnancy, and the postpartum period. It will observe any safety and tolerability of the medications used by the mother, and will measure the level of darunavir/r and/or 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 during which 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/ritonavir twice daily, 12 evaluable patients taking etravirine and 12 evaluable patients taking rilpivirine 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/r) and/or etravirine or rilpivirine during the second and third trimesters of gestation, as well as postpartum. Information collected in this study may be analyzed after either 12 patients on darunavir/r once daily or 12 patients on darunavir/r twice daily or 12 patients on etravirine or 12 patients on rilpivirine have completed their last visit. A final analysis will be completed after all 48 patients have completed their last visit. 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. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant females (13-24 weeks of gestation)
  • documented HIV-1 infection
  • Receiving darunavir/ritonavir and/or etravirine at the time of entry into the study
  • Willing to remain on darunavir/ritonavir and/or etravirine and rilpivirine as well as a background regimen for the duration of their pregnancy and 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855335

Contacts
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: JNJ.CT@sylogent.com

Locations
United States, Florida
Recruiting
Daytona Beach, Florida, United States
Completed
Jacksonville, Florida, United States
Recruiting
Miami, Florida, United States
Completed
Pensacola, Florida, United States
Completed
Port Saint Lucie, Florida, United States
Recruiting
West Palm Beach, Florida, United States
United States, Massachusetts
Completed
Springfield, Massachusetts, United States
United States, Michigan
Completed
Dearborn, Michigan, United States
United States, New York
Completed
Bronx, New York, United States
United States, North Carolina
Completed
Chapel Hill, North Carolina, United States
United States, Pennsylvania
Completed
Philadelphia, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Puerto Rico
Recruiting
San Juan Pr, Puerto Rico
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00855335     History of Changes
Other Study ID Numbers: CR015442, TMC114HIV3015
Study First Received: March 2, 2009
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration
Puerto Rico: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Janssen Scientific Affairs, LLC:
HIV-1
HIV
Human immunodeficiency virus
PREZISTA
TMC114
darunavir
Pregnancy
Postpartum
INTELENCE
NORVIR
TMC125
ritonavir
etravirine
rilpivirine
TMC278
treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Darunavir
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Etravirine
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014