Status:
RECRUITING
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
PENTA Foundation
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
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...
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, TMC11...
Eligibility Criteria
Inclusion
- HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
- 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 a cART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
- Subject is pregnant
- Subject is able to adhere to food intake recommendations, if applicable.
Exclusion
- 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).
- Using oral cabotegravir/rilpivirine.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00825929
Start Date
February 1 2009
End Date
December 1 2026
Last Update
January 13 2025
Active Locations (21)
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1
Saint-Pierre University Hospital; Department of Infectious Diseases
Brussels, Belgium
2
CHARITÉ Berlin
Berlin, Germany
3
University of Bonn
Bonn, Germany
4
University of Cologne
Cologne, Germany