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

January 19, 2009
June 20, 2014
February 2009
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00825929 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

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.

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

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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.

Non-Probability Sample

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

HIV Infections
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
December 2015
December 2015   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact: David M Burger, PharmD PhD ++31 24 3616405 dadvid.burger@radboudumc.nl
Contact: Angela Colbers, MSc ++31 24 3616405 angela.colbers@radboudumc.nl
Belgium,   Canada,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00825929
UMCN-AKF 08.02
No
Radboud University
Radboud University
  • PENTA Foundation
  • Merck Sharp & Dohme Corp.
  • Bristol-Myers Squibb
  • Janssen Pharmaceutica
Principal Investigator: David M Burger, PharmD PhD Radboud University Medical Centre Nijmegen
Radboud University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP