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AzTrials

HIV InfectionsPANNANCT00825929

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

An observational study of HIV Infections, run by Radboud University Medical Center at 21 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV Infections
How many people
176 participants
Where
21 sitesin 7 countries
Study dates
Feb 2009to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV-infected pregnant women using at least one of the following antiretroverial agents: 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 LA

Who may be able to join

  • HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
  • 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 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.
  • Subject is pregnant
  • Subject is able to adhere to food intake recommendations, if applicable.

Who cannot join

  • 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).
  • Using oral cabotegravir/rilpivirine.

Trial locations and contacts

21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

David M Burger, PharmD PhD contact

++31 24 3616405

david.burger@radboudumc.nl

Wendy van der Wekken, MSc contact

21 sites in 7 countries

United Kingdom6 sites, 3 recruiting

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton

    Yvonne Gilleece

    Yvonne Gilleece

    Recruiting

  • C&W Hospital, London

    London

    David Hawkins, MD, PhD

    Recruiting

  • North Middlesex Hospital

    London

    Completed

  • St Mary's Hospital, London

    London

    Graham Taylor, MD, PhD

    Recruiting

  • St Thomas Hospital

    London

    Withdrawn

  • St. George's Hospital, London

    London

    Completed

Other trials in United Kingdom

Germany5 sites, 5 recruiting

  • CHARITÉ Berlin

    Berlin

    Katharina von Weizsaecker, katharina.weizsaecker@charite.de

    Katharina von Weizsaecker, MD

    Recruiting

  • University of Bonn

    Bonn

    Juergen Rockstroh, MD, PhD

    Recruiting

  • University of Cologne

    Cologne

    J Malin

    Recruiting

  • Johann Wolfgang Goethe-Universität

    Frankfurt am Main

    Anette Haberl, Annette.Haberl@hivcenter.de

    Annette Haberl, MD

    Recruiting

  • University München

    München

    B Kost

    B Kost, MD

    Recruiting

Other trials in Germany

Netherlands4 sites, 3 recruiting

  • AMC

    Amsterdam

    Completed

  • Radboud University Nijmegen Medical Centre

    Nijmegen

    van Crevel, Md. PhD

    Recruiting

  • Erasmus Medical Center Rotterdam

    Rotterdam

    Rokx, MD, PhD

    Recruiting

  • St Elisabeth hospital

    Tilburg

    Marjo van Kasteren

    Marjo van Kasteren

    Recruiting

Other trials in Netherlands

Ireland2 sites, 2 recruiting

  • Mater Hospital and UCD

    Dublin

    John Lambert, jlambert@mater.ie

    John Lambert, MD

    Recruiting

  • St James's Hospital Dublin

    Dublin

    Fiona Lyons, FLyons@STJAMES.IE

    Fiona Lyons, MD

    Recruiting

Other trials in Ireland

Spain2 sites, 2 recruiting

  • Hospital Universitari Germans Trias i Pujol, Badalona

    Badalona

    Jose Molto, MD, PhD

    Recruiting

  • Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna

    Granada

    Carmen Hidalgo Tenori, chidalgo72@hotmail.com

    Carmen Hidalgo Tenori, MD

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • Saint-Pierre University Hospital; Department of Infectious Diseases

    Brussels

    D Konopnicki

    D Konopnicki, MD

    Recruiting

Other trials in Belgium

Italy1 site

  • IRCSS

    Rome

    Completed

Other trials in Italy

About this study

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

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.

Read the 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; cabotegravir/rilpivirine long acting injectables

Conditions
HIV Infections
Keywords
pharmacokinetics, pregnancy, antiretrovirals, neonates, HIV, treatment experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00825929
Study groupRoleWhat they receive
1Treated with one of the antiretroviral agents under study, PK parameters during pregnancy will be compared with PK parameters after pregnancy (within the same woman)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery

    Measured: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery

Secondary outcomes (3)

  1. Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.

    Measured: Week 1, 3 and between 4 and 6

  2. Safety of antiretrovirals during pregnancy

    Measured: GA Week 33 until end of trial

  3. viral load response and prevention of mother to child transmission of the virus

    Measured: GA Week 3 and at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00825929
Sponsor's protocol ID
UMCN-AKF 08.02
Acronym
PANNA
Status last verified
Jan 2025
First submitted
19 Jan 2009
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No

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.

    PubMed 23169329

  • 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.

    PubMed 24413315

  • 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.

    PubMed 32103260

  • 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.

    PubMed 39909979

  • 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.

    PubMed 32330231

  • 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.

    PubMed 30530925

  • 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.

    PubMed 28595298

  • 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.

    PubMed 27540363

  • 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.

    PubMed 26202768

  • 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.

    PubMed 25944344

  • 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.

    PubMed 25326090

  • 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.

    PubMed 24992294

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Radboud University Medical Center at 21 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, Germany, Netherlands, Ireland, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David M Burger, PharmD PhD (++31 24 3616405, david.burger@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00825929, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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