Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. (PANNA)
This study is currently recruiting participants.
Verified November 2012 by Radboud University
Sponsor:
Radboud University
Collaborators:
PENTA Foundation
Merck
Bristol-Myers Squibb
Janssen Pharmaceutica
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00825929
First received: January 19, 2009
Last updated: November 12, 2012
Last verified: November 2012
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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: | March 2015 |
| Estimated Primary Completion Date: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825929
Contacts
| Contact: David M Burger, PharmD PhD | ++31 24 3616405 | d.burger@akf.umcn.nl |
| Contact: Angela Colbers, MSc | ++31 24 3616405 | a.colbers@akf.umcn.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 | |
| C&W Hospital, London | Recruiting |
| London, United Kingdom | |
| Principal Investigator: David Hawkins, MD, PhD | |
| 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 | |
Sponsors and Collaborators
Radboud University
PENTA Foundation
Merck
Bristol-Myers Squibb
Janssen Pharmaceutica
Investigators
| Principal Investigator: | David M Burger, PharmD PhD | Radboud University Medical Centre Nijmegen |
More Information
No publications provided
| 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: | November 12, 2012 |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013