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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00825929
Recruitment Status : Recruiting
First Posted : January 21, 2009
Last Update Posted : July 13, 2020
Sponsor:
Collaborators:
PENTA Foundation
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Janssen Pharmaceutica
ViiV Healthcare
Information provided by (Responsible Party):
Radboud University

Study Description
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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
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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 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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)


Outcome Measures
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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, Older Adult)
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
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
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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


Contacts
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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
Show Show 24 study locations
Sponsors and Collaborators
Radboud University
PENTA Foundation
Merck Sharp & Dohme Corp.
Bristol-Myers Squibb
Janssen Pharmaceutica
ViiV Healthcare
Investigators
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Principal Investigator: David M Burger, PharmD PhD Radboud University Medical Centre Nijmegen
More Information
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Additional Information:

Publications of Results:

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

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00825929    
Other Study ID Numbers: UMCN-AKF 08.02
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Keywords provided by Radboud University:
pharmacokinetics
pregnancy
antiretrovirals
 neonates
HIV
treatment experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases