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

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ClinicalTrials.gov Identifier: NCT00825929
Recruitment Status : Recruiting
First Posted : January 21, 2009
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
HIV Infections

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; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat

Study Design

Study Type : Observational
Estimated Enrollment : 176 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
Study Start Date : February 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety of antiretrovirals during pregnancy [ Time Frame: GA Week 33 until end of trial ]
  3. viral load response and prevention of mother to child transmission of the virus [ Time Frame: GA Week 3 and at delivery ]

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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825929

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

Saint-Pierre University Hospital; Department of Infectious Diseases Recruiting
Brussels, Belgium
Contact: D Konopnicki         
Principal Investigator: D Konopnicki, MD         
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: Irene Alba         
Principal Investigator: B Kost, MD         
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         
IRCSS Recruiting
Rome, Italy
Principal Investigator: A Antinori, MD         
AMC Not yet recruiting
Amsterdam, Netherlands
Contact: Jeannine Nellen, MD, PhD         
Principal Investigator: Jeannine Nellen, MD, PhD         
AMC Recruiting
Amsterdam, Netherlands
Contact: Jeannine Nellen         
Principal Investigator: Jeannine Nellen         
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         
St Elisabeth hospital Recruiting
Tilburg, Netherlands
Contact: Marjo van Kasteren         
Principal Investigator: Marjo van Kasteren         
St Elisabeth Ziekenhuis Recruiting
Tilburg, Netherlands
Contact: M van Kasteren         
Principal Investigator: M van Kasteren, MD         
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
Brighton and Sussex University Hospitals NHS Trust Recruiting
Brighton, United Kingdom
Contact: Yvonne Gilleece         
Principal Investigator: Yvonne Gilleece         
C&W Hospital, London Recruiting
London, United Kingdom
Principal Investigator: David Hawkins, MD, PhD         
North Middlesex Hospital Recruiting
London, United Kingdom
Contact: Chris Wood         
Principal Investigator: Chris Wood         
North Middlesex Hospital Recruiting
London, United Kingdom
Contact: C Wood         
Principal Investigator: C Wood, MD         
St Mary's Hospital, London Recruiting
London, United Kingdom
Principal Investigator: Graham Taylor, MD, PhD         
St Thomas Hospital Not yet recruiting
London, United Kingdom
Contact: J Fox         
Principal Investigator: J Fox, MD         
St. George's Hospital, London Recruiting
London, United Kingdom
Principal Investigator: Tariq Sadiq, PhD         
Sponsors and Collaborators
Radboud University
PENTA Foundation
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Janssen Pharmaceutica
ViiV Healthcare
Principal Investigator: David M Burger, PharmD PhD Radboud University Medical Centre Nijmegen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00825929     History of Changes
Other Study ID Numbers: UMCN-AKF 08.02
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Radboud University:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents