Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

HIV Infections Clinical Trial

— PANNA  

Official title:

Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825929
• Other study ID #: UMCN-AKF 08.02
• Status: Recruiting
• Start date: February 2009
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: Radboud University Medical Center
• Contact: David M Burger, PharmD PhD
• Phone: ++31 24 3616405
• Email: dadvid.burger[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Belgium	Saint-Pierre University Hospital; Department of Infectious Diseases	Brussels
Germany	CHARITÉ Berlin	Berlin
Germany	University of Bonn	Bonn
Germany	University of Cologne	Cologne
Germany	Johann Wolfgang Goethe-Universität	Frankfurt am Main
Germany	University München	München
Ireland	Mater Hospital and UCD	Dublin
Ireland	St James's Hospital Dublin	Dublin
Italy	IRCSS	Rome
Netherlands	AMC	Amsterdam
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	Erasmus Medical Center Rotterdam	Rotterdam
Netherlands	St Elisabeth hospital	Tilburg
Spain	Hospital Universitari Germans Trias i Pujol, Badalona	Badalona
Spain	Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna	Granada
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton
United Kingdom	C&W Hospital, London	London
United Kingdom	North Middlesex Hospital	London
United Kingdom	St Mary's Hospital, London	London
United Kingdom	St Thomas Hospital	London
United Kingdom	St. George's Hospital, London	London

Sponsors (7)

Lead Sponsor	Collaborator
Radboud University Medical Center	Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceutica, Merck Sharp & Dohme LLC, PENTA Foundation, ViiV Healthcare

Countries where clinical trial is conducted

Belgium,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (3)

Bollen P, Freriksen J, Konopnicki D, Weizsacker K, Hidalgo Tenorio C, Molto J, Taylor G, Alba-Alejandre I, van Crevel R, Colbers A, Burger D; Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women Network. The Effect of Pregnancy on the — View Citation

Colbers A, Gingelmaier A, van der Ende M, Rijnders B, Burger D. Pharmacokinetics, safety and transplacental passage of rilpivirine in pregnancy: two cases. AIDS. 2014 Jan 14;28(2):288-90. doi: 10.1097/QAD.0000000000000100. No abstract available. — View Citation

Colbers AP, Hawkins DA, Gingelmaier A, Kabeya K, Rockstroh JK, Wyen C, Weizsacker K, Sadiq ST, Ivanovic J, Giaquinto C, Taylor GP, Molto J, Burger DM; PANNA network. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infecte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery		PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
Secondary	Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.		Week 1, 3 and between 4 and 6
Secondary	Safety of antiretrovirals during pregnancy		GA Week 33 until end of trial
Secondary	viral load response and prevention of mother to child transmission of the virus		GA Week 3 and at delivery

External Links

•   PANNA study website