Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR)
NCT07737340
Blood-Borne Infections, Communicable Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT00825929
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Saint-Pierre University Hospital; Department of Infectious Diseases, Brussels, Belgium
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; cabotegravir/rilpivirine long acting injectables
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
Time frame: Week 1, 3 and between 4 and 6
Time frame: GA Week 33 until end of trial
Time frame: GA Week 3 and at delivery
Contact information is provided by the study sponsor or research team.
David M Burger, PharmD PhD
CONTACT
++31 24 3616405
Wendy van der Wekken, MSc
CONTACT
Radboud University Medical Center
Other
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
Acronym: PANNA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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