NCT00825929RecruitingPhase 4
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
Source: ClinicalTrials.gov · Last updated 13 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Observational
- Enrollment
- 176 (estimated)
- First submitted
- 19 Jan 2009
- Start date
- 1 Feb 2009
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Radboud University Medical Center
- Diseases
- HIV
- NCT number
- NCT00825929
- EU CT number
- 2024-515487-31-00
- EudraCT number
- 2008-006158-16
What you commit to
- Study type: Observational · Phase 4
- Planned participants: 176
- From 1 Feb 2009 to the primary completion date, 31 Dec 2026
- 23 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
Lab values
- Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL).
Other
- Inability to understand the nature and extent of the study and the procedures required.
- Using oral cabotegravir/rilpivirine.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| University of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Brighton and Sussex University Hospitals NHS Trust Coordinator of this site? Confirm its status | Brighton | United Kingdom | Recruiting |
| St Mary's Hospital, London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Withdrawn |
| C&W Hospital, London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| North Middlesex Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Completed |
| St. George's Hospital, London Coordinator of this site? Confirm its status | London | United Kingdom | Completed |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| IRCSS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.