Pharmacokinetics of Antiretroviral Agents in HIV-Infected Pregnant Women. - Full Text View

Sponsors and Collaborators:	Radboud University PENTA Foundation
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00825929

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

MedlinePlus related topics: AIDS AIDS and Pregnancy

U.S. FDA Resources

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

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

Biospecimen Description:

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 2012
Estimated Primary Completion Date:	January 2012 (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

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

France
Hospital Pitié-Salpétrière, Paris	Not yet recruiting
Paris, France
Principal Investigator: Ronald Tubiana, MD, PhD
Germany
University of Cologne	Not yet recruiting
Cologne, Germany
Principal Investigator: Gerd Faetkenheuer, MD, PhD
University of Bonn	Not yet recruiting
Bonn, Germany
Principal Investigator: Juergen Rockstroh, MD, PhD
Italy
University of Torino	Not yet recruiting
Torino, Italy
Principal Investigator: Giovanni di Perri, MD, PhD
IRCSS	Not yet recruiting
Rome, Italy
Principal Investigator: Adriana Ammassari, Md. PhD
University of Padua	Not yet recruiting
Padua, Italy
Principal Investigator: Carlo Giaquinto, Md, PhD
Netherlands
Erasmus Medical Center Rotterdam	Not yet recruiting
Rotterdam, Netherlands
Principal Investigator: Ineke van der Ende, MD, PhD
Radboud University Nijmegen Medical Centre	Recruiting
Nijmegen, Netherlands
Principal Investigator: Andre van der Ven, Md. PhD
AMC	Not yet recruiting
Amsterdam, Netherlands
Contact: Jeannine Nellen, MD, PhD
Principal Investigator: Jeannine Nellen, MD, PhD
Spain
Hospital Universitari Germans Trias I Pujol, Badalona	Not yet recruiting
Badalona, Spain
Principal Investigator: Jose Molto, MD, PhD
Switzerland
University Hospital Geneva	Not yet recruiting
Geneva, Switzerland
Contact: Bernard Hirschel, MD, PhD
Principal Investigator: Bernard Hirschel, MD, PhD
United Kingdom
St. George's Hospital, London	Not yet recruiting
London, United Kingdom
Principal Investigator: Tariq Sadiq, PhD
St Mary's Hospital, London	Not yet recruiting
London, United Kingdom
Principal Investigator: Graham Taylor, MD, PhD
C&W Hospital, London	Not yet recruiting
London, United Kingdom
Principal Investigator: David Hawkins, MD, PhD

Sponsors and Collaborators

Radboud University

PENTA Foundation

Investigators

Principal Investigator:

David M Burger, PharmD PhD

Radboud University Medical Centre Nijmegen

More Information

No publications provided

Responsible Party:	Radboud University Medical Centre ( David M Burger )
Study ID Numbers:	UMCN-AKF 08.02
Study First Received:	January 19, 2009
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00825929 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

pharmacokinetics
pregnancy
antiretrovirals
neonates

HIV
pregnancy
treatment experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009