- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825929
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. (PANNA)
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
Study Overview
Status
Conditions
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, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David M Burger, PharmD PhD
- Phone Number: ++31 24 3616405
- Email: dadvid.burger@radboudumc.nl
Study Contact Backup
- Name: Angela Colbers, MSc
- Phone Number: ++31 24 3616405
- Email: angela.colbers@radboudumc.nl
Study Locations
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Brussels, Belgium
- Recruiting
- Saint-Pierre University Hospital; Department of Infectious Diseases
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Contact:
- D Konopnicki
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Principal Investigator:
- D Konopnicki, MD
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Berlin, Germany
- Recruiting
- Charité Berlin
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Contact:
- Katharina von Weizsaecker
- Email: katharina.weizsaecker@charite.de
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Principal Investigator:
- Katharina von Weizsaecker, MD
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Bonn, Germany
- Recruiting
- University of Bonn
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Principal Investigator:
- Juergen Rockstroh, MD, PhD
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Cologne, Germany
- Recruiting
- University of Cologne
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Principal Investigator:
- Gerd Faetkenheuer, MD, PhD
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Frankfurt am Main, Germany
- Recruiting
- Johann Wolfgang Goethe-Universität
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Contact:
- Anette Haberl
- Email: Annette.Haberl@hivcenter.de
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Principal Investigator:
- Annette Haberl, MD
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München, Germany
- Recruiting
- University München
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Contact:
- Irene Alba
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Principal Investigator:
- B Kost, MD
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Dublin, Ireland
- Recruiting
- Mater Hospital and UCD
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Contact:
- John Lambert
- Email: jlambert@mater.ie
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Principal Investigator:
- John Lambert, MD
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Dublin, Ireland
- Recruiting
- St James's Hospital Dublin
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Contact:
- Fiona Lyons
- Email: FLyons@STJAMES.IE
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Principal Investigator:
- Fiona Lyons, MD
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Rome, Italy
- Completed
- IRCSS
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Amsterdam, Netherlands
- Completed
- AMC
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Nijmegen, Netherlands
- Recruiting
- Radboud University Nijmegen Medical Centre
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Principal Investigator:
- Andre van der Ven, Md. PhD
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Rotterdam, Netherlands
- Recruiting
- Erasmus Medical Center Rotterdam
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Principal Investigator:
- Ineke van der Ende, MD, PhD
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Tilburg, Netherlands
- Recruiting
- St Elisabeth Hospital
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Contact:
- Marjo van Kasteren
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Principal Investigator:
- Marjo van Kasteren
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Badalona, Spain
- Recruiting
- Hospital Universitari Germans Trias i Pujol, Badalona
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Principal Investigator:
- Jose Molto, MD, PhD
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Granada, Spain
- Recruiting
- Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna
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Contact:
- Carmen Hidalgo Tenori
- Email: chidalgo72@hotmail.com
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Principal Investigator:
- Carmen Hidalgo Tenori, MD
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Brighton, United Kingdom
- Recruiting
- Brighton and Sussex University Hospitals NHS Trust
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Contact:
- Yvonne Gilleece
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Principal Investigator:
- Yvonne Gilleece
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London, United Kingdom
- Recruiting
- C&W Hospital, London
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Principal Investigator:
- David Hawkins, MD, PhD
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London, United Kingdom
- Completed
- North Middlesex Hospital
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London, United Kingdom
- Recruiting
- St Mary's Hospital, London
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Principal Investigator:
- Graham Taylor, MD, PhD
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London, United Kingdom
- Withdrawn
- St Thomas Hospital
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London, United Kingdom
- Completed
- St. George's Hospital, London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery
Time Frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
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PK curve in Week 33 of pregnancy and 4-6 weeks after delivery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.
Time Frame: Week 1, 3 and between 4 and 6
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Week 1, 3 and between 4 and 6
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Safety of antiretrovirals during pregnancy
Time Frame: GA Week 33 until end of trial
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GA Week 33 until end of trial
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viral load response and prevention of mother to child transmission of the virus
Time Frame: GA Week 3 and at delivery
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GA Week 3 and at delivery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David M Burger, PharmD PhD, Radboud University Medical Centre Nijmegen
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCN-AKF 08.02
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