Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

  • STATUS
    Recruiting
  • End date
    Dec 19, 2025
  • participants needed
    176
  • sponsor
    Radboud University
Updated on 19 July 2021
antiretroviral
antiretroviral agents
haart
hiv antibody
HIV Vaccine
immune globulin
antibody test
hiv antibodies

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.

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; doravirine; bictegravir

Details
Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Clinical Study IdentifierNCT00825929
SponsorRadboud University
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

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)
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