Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. (PANNA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Radboud University
Sponsor:
Collaborators:
PENTA Foundation
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Janssen Pharmaceutica
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00825929
First received: January 19, 2009
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery [ Time Frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study. [ Time Frame: Week 1, 3 and between 4 and 6 ] [ Designated as safety issue: No ]
  • Safety of antiretrovirals during pregnancy [ Time Frame: GA Week 33 until end of trial ] [ Designated as safety issue: Yes ]
  • viral load response and prevention of mother to child transmission of the virus [ Time Frame: GA Week 3 and at delivery ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Plasma samples will be collected in Week 33 of the pregnancy and at 4-6 weeks after delivery. At the following time points samples will be collected: T=0 (prior to dosing), and T=1, 2, 3, 4, 6, 8, 12 and 24h (24h sample only in case of QD regimen) post-dosing (8 or 9 samples).

In case the infant needs post-exposure prophylaxis with at least one of the agents sparse PK sampling is optional.


Estimated Enrollment: 176
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Treated with one of the antiretroviral agents under study, PK parameters during pregnancy will be compared with PK parameters after pregnancy (within the same woman)

Detailed Description:

The following agents will be studied:

Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; Raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected pregnant women using at least one of the following antiretroverial agents: Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; Raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; Abacavir; Rilpivirine

Criteria

Inclusion Criteria:

  • HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
  • Subject is at least 18 years of age at screening.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • Treated with an HAART regimen containing at least one agent which is mentioned in Appendix 1 of the protocol; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
  • Duration of pregnancy not longer than 33 weeks at the day of screening
  • Subject is able to adhere to food intake recommendations.

Exclusion Criteria:

  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • Inability to understand the nature and extent of the study and the procedures required.
  • Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)
  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: NCT00825929

Contacts
Contact: David M Burger, PharmD PhD ++31 24 3616405 dadvid.burger@radboudumc.nl
Contact: Angela Colbers, MSc ++31 24 3616405 angela.colbers@radboudumc.nl

Locations
Belgium
Saint-Pierre University Hospital; Department of Infectious Diseases Recruiting
Brussels, Belgium
Contact: Kabeya       Kabamba_KABEYA@stpierre-bru.be   
Principal Investigator: Kabeya, MD         
Canada
Ottawa Hospital Research Institute, Faculty of Medicine, University of Ottawa Not yet recruiting
Ottawa, Canada
Contact: Charles la Porte         
Principal Investigator: Charles la Porte, PhD         
Germany
CHARITÉ Berlin Recruiting
Berlin, Germany
Contact: Katharina von Weizsaecker       katharina.weizsaecker@charite.de   
Principal Investigator: Katharina von Weizsaecker, MD         
University of Bonn Recruiting
Bonn, Germany
Principal Investigator: Juergen Rockstroh, MD, PhD         
University of Cologne Recruiting
Cologne, Germany
Principal Investigator: Gerd Faetkenheuer, MD, PhD         
Johann Wolfgang Goethe-Universität Recruiting
Frankfurt am Main, Germany
Contact: Anette Haberl       Annette.Haberl@hivcenter.de   
Principal Investigator: Annette Haberl, MD         
University München Recruiting
München, Germany
Contact: Andrea Gingelmaier       andrea.gingelmaier@med.uni-muenchen.de   
Principal Investigator: Andrea Gingelmaier, MD         
Ireland
Mater Hospital and UCD Recruiting
Dublin, Ireland
Contact: John Lambert       jlambert@mater.ie   
Principal Investigator: John Lambert, MD         
St James's Hospital Dublin Recruiting
Dublin, Ireland
Contact: Fiona Lyons       FLyons@STJAMES.IE   
Principal Investigator: Fiona Lyons, MD         
Italy
IRCSS Recruiting
Rome, Italy
Principal Investigator: Jelena Ivanovic, MD         
Netherlands
AMC Not yet recruiting
Amsterdam, Netherlands
Contact: Jeannine Nellen, MD, PhD         
Principal Investigator: Jeannine Nellen, MD, PhD         
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands
Principal Investigator: Andre van der Ven, Md. PhD         
Erasmus Medical Center Rotterdam Recruiting
Rotterdam, Netherlands
Principal Investigator: Ineke van der Ende, MD, PhD         
Spain
Hospital Universitari Germans Trias i Pujol, Badalona Recruiting
Badalona, Spain
Principal Investigator: Jose Molto, MD, PhD         
Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna Recruiting
Granada, Spain
Contact: Carmen Hidalgo Tenori       chidalgo72@hotmail.com   
Principal Investigator: Carmen Hidalgo Tenori, MD         
United Kingdom
St Mary's Hospital, London Recruiting
London, United Kingdom
Principal Investigator: Graham Taylor, MD, PhD         
St. George's Hospital, London Recruiting
London, United Kingdom
Principal Investigator: Tariq Sadiq, PhD         
C&W Hospital, London Recruiting
London, United Kingdom
Principal Investigator: David Hawkins, MD, PhD         
Sponsors and Collaborators
Radboud University
PENTA Foundation
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Janssen Pharmaceutica
Investigators
Principal Investigator: David M Burger, PharmD PhD Radboud University Medical Centre Nijmegen
  More Information

Publications:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00825929     History of Changes
Other Study ID Numbers: UMCN-AKF 08.02
Study First Received: January 19, 2009
Last Updated: June 20, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
pharmacokinetics
pregnancy
antiretrovirals
neonates
HIV
treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
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
Anti-Retroviral Agents
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014