Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
NCT ID: NCT00825929
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
176 participants
OBSERVATIONAL
2009-02-28
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Subject is at least 18 years of age at screening.
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. 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.
5. Subject is pregnant
6. Subject is able to adhere to food intake recommendations, if applicable.
Exclusion Criteria
2. Inability to understand the nature and extent of the study and the procedures required.
3. Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL).
4. Using oral cabotegravir/rilpivirine.
18 Years
FEMALE
No
Sponsors
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PENTA Foundation
NETWORK
Merck Sharp & Dohme LLC
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Janssen Pharmaceutica
INDUSTRY
ViiV Healthcare
INDUSTRY
Gilead Sciences
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David M Burger, PharmD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Centre Nijmegen
Locations
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Saint-Pierre University Hospital; Department of Infectious Diseases
Brussels, , Belgium
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, , Germany
Mater Hospital and UCD
Dublin, , Ireland
St James's Hospital Dublin
Dublin, , Ireland
IRCSS
Rome, , Italy
AMC
Amsterdam, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Erasmus Medical Center Rotterdam
Rotterdam, , Netherlands
St Elisabeth hospital
Tilburg, , Netherlands
Hospital Universitari Germans Trias i Pujol, Badalona
Badalona, , Spain
Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna
Granada, , Spain
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, , United Kingdom
Countries
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Central Contacts
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Wendy van der Wekken, MSc
Role: CONTACT
Facility Contacts
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D Konopnicki
Role: primary
B Kost
Role: primary
Marjo van Kasteren
Role: primary
Yvonne Gilleece
Role: primary
References
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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-infected pregnant women. AIDS. 2013 Mar 13;27(5):739-48. doi: 10.1097/QAD.0b013e32835c208b.
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.
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 Pharmacokinetics of Total and Unbound Dolutegravir and Its Main Metabolite in Women Living With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jan 23;72(1):121-127. doi: 10.1093/cid/ciaa006.
Overbeek JK, van Erp NP, Burger DM, den Broeder AA, Koolen SLW, Huitema ADR, Ter Heine R. Population Pharmacokinetics of Cobicistat and its Effect on the Pharmacokinetics of the Anticancer Drug Olaparib. Clin Pharmacokinet. 2025 Mar;64(3):425-435. doi: 10.1007/s40262-025-01480-w. Epub 2025 Feb 5.
Bukkems V, Necsoi C, Tenorio CH, Garcia C, Rockstroh J, Schwarze-Zander C, Lambert JS, Burger D, Konopnicki D, Colbers A. Clinically Significant Lower Elvitegravir Exposure During the Third Trimester of Pregnant Patients Living With Human Immunodeficiency Virus: Data From the Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) Network. Clin Infect Dis. 2020 Dec 17;71(10):e714-e717. doi: 10.1093/cid/ciaa488.
Kreitchmann R, Schalkwijk S, Best B, Wang J, Colbers A, Stek A, Shapiro D, Cressey T, Mirochnick M, Burger D. Efavirenz pharmacokinetics during pregnancy and infant washout. Antivir Ther. 2019;24(2):95-103. doi: 10.3851/IMP3283.
Schalkwijk S, Colbers A, Konopnicki D, Gingelmaier A, Lambert J, van der Ende M, Molto J, Burger D; Pharmacokinetics of newly developed antiretroviral agents in HIV-infected pregnant women (PANNA) Network. Lowered Rilpivirine Exposure During the Third Trimester of Pregnancy in Human Immunodeficiency Virus Type 1-Infected Women. Clin Infect Dis. 2017 Oct 15;65(8):1335-1341. doi: 10.1093/cid/cix534.
Mulligan N, Schalkwijk S, Best BM, Colbers A, Wang J, Capparelli EV, Molto J, Stek AM, Taylor G, Smith E, Hidalgo Tenorio C, Chakhtoura N, van Kasteren M, Fletcher CV, Mirochnick M, Burger D. Etravirine Pharmacokinetics in HIV-Infected Pregnant Women. Front Pharmacol. 2016 Aug 4;7:239. doi: 10.3389/fphar.2016.00239. eCollection 2016.
Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.
Blonk MI, Colbers AP, Hidalgo-Tenorio C, Kabeya K, Weizsacker K, Haberl AE, Molto J, Hawkins DA, van der Ende ME, Gingelmaier A, Taylor GP, Ivanovic J, Giaquinto C, Burger DM; Pharmacokinetics of Newly Developed Antiretroviral Agents in HIV-Infected Pregnant Women PANNA Network; PANNA Network. Raltegravir in HIV-1-Infected Pregnant Women: Pharmacokinetics, Safety, and Efficacy. Clin Infect Dis. 2015 Sep 1;61(5):809-16. doi: 10.1093/cid/civ366. Epub 2015 May 5.
Colbers A, Molto J, Ivanovic J, Kabeya K, Hawkins D, Gingelmaier A, Taylor G, Weizsacker K, Sadiq ST, Van der Ende M, Giaquinto C, Burger D; PANNA Network. Pharmacokinetics of total and unbound darunavir in HIV-1-infected pregnant women. J Antimicrob Chemother. 2015 Feb;70(2):534-42. doi: 10.1093/jac/dku400. Epub 2014 Oct 17.
Colbers A, Hawkins D, Hidalgo-Tenorio C, van der Ende M, Gingelmaier A, Weizsacker K, Kabeya K, Taylor G, Rockstroh J, Lambert J, Molto J, Wyen C, Sadiq ST, Ivanovic J, Giaquinto C, Burger D; PANNA network. Atazanavir exposure is effective during pregnancy regardless of tenofovir use. Antivir Ther. 2015;20(1):57-64. doi: 10.3851/IMP2820. Epub 2014 Jul 3.
Related Links
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PANNA study website
Other Identifiers
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UMCN-AKF 08.02
Identifier Type: -
Identifier Source: org_study_id
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