Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. (PANNA)

November 28, 2022 updated by: Radboud University Medical Center

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Brussels, Belgium
        • Recruiting
        • Saint-Pierre University Hospital; Department of Infectious Diseases
        • Contact:
          • D Konopnicki
        • Principal Investigator:
          • D Konopnicki, MD
      • Berlin, Germany
      • Bonn, Germany
        • Recruiting
        • University of Bonn
        • Principal Investigator:
          • Juergen Rockstroh, MD, PhD
      • Cologne, Germany
        • Recruiting
        • University of Cologne
        • Principal Investigator:
          • Gerd Faetkenheuer, MD, PhD
      • Frankfurt am Main, Germany
        • Recruiting
        • Johann Wolfgang Goethe-Universität
        • Contact:
        • Principal Investigator:
          • Annette Haberl, MD
      • München, Germany
        • Recruiting
        • University München
        • Contact:
          • Irene Alba
        • Principal Investigator:
          • B Kost, MD
      • Dublin, Ireland
        • Recruiting
        • Mater Hospital and UCD
        • Contact:
        • Principal Investigator:
          • John Lambert, MD
      • Dublin, Ireland
        • Recruiting
        • St James's Hospital Dublin
        • Contact:
        • Principal Investigator:
          • Fiona Lyons, MD
      • Rome, Italy
        • Completed
        • IRCSS
      • Amsterdam, Netherlands
        • Completed
        • AMC
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud University Nijmegen Medical Centre
        • Principal Investigator:
          • Andre van der Ven, Md. PhD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center Rotterdam
        • Principal Investigator:
          • Ineke van der Ende, MD, PhD
      • Tilburg, Netherlands
        • Recruiting
        • St Elisabeth Hospital
        • Contact:
          • Marjo van Kasteren
        • Principal Investigator:
          • Marjo van Kasteren
      • Badalona, Spain
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol, Badalona
        • Principal Investigator:
          • Jose Molto, MD, PhD
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna
        • Contact:
        • Principal Investigator:
          • Carmen Hidalgo Tenori, MD
      • Brighton, United Kingdom
        • Recruiting
        • Brighton and Sussex University Hospitals NHS Trust
        • Contact:
          • Yvonne Gilleece
        • Principal Investigator:
          • Yvonne Gilleece
      • London, United Kingdom
        • Recruiting
        • C&W Hospital, London
        • Principal Investigator:
          • David Hawkins, MD, PhD
      • London, United Kingdom
        • Completed
        • North Middlesex Hospital
      • London, United Kingdom
        • Recruiting
        • St Mary's Hospital, London
        • Principal Investigator:
          • Graham Taylor, MD, PhD
      • London, United Kingdom
        • Withdrawn
        • St Thomas Hospital
      • London, United Kingdom
        • Completed
        • St. George's Hospital, London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
PK curve in Week 33 of pregnancy and 4-6 weeks after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 1, 3 and between 4 and 6
Safety of antiretrovirals during pregnancy
Time Frame: GA Week 33 until end of trial
GA Week 33 until end of trial
viral load response and prevention of mother to child transmission of the virus
Time Frame: GA Week 3 and at delivery
GA Week 3 and at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David M Burger, PharmD PhD, Radboud University Medical Centre Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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