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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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Saint-Pierre
Coordinator of this site? Confirm its status
BrusselsBelgiumCompleted
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
Coordinator of this site? Confirm its status
BonnGermanyCompleted
University of Cologne
Coordinator of this site? Confirm its status
CologneGermanyCompleted
Goethe University Frankfurt
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyCompleted
Klinikum der Universitaet Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyCompleted
Hospital Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital Universitario Virgen de las Nieves
Coordinator of this site? Confirm its status
GranadaSpainCompleted
Brighton and Sussex University Hospitals NHS Trust
Coordinator of this site? Confirm its status
BrightonUnited KingdomRecruiting
St Mary's Hospital, London
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
St Thomas Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomWithdrawn
C&W Hospital, London
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
North Middlesex Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomCompleted
St. George's Hospital, London
Coordinator of this site? Confirm its status
LondonUnited KingdomCompleted
Mater Misericordiae University Hospital
Coordinator of this site? Confirm its status
Dublin 7IrelandCompleted
St James's Hospital
Coordinator of this site? Confirm its status
Dublin 8IrelandCompleted
IRCSS
Coordinator of this site? Confirm its status
RomeItalyCompleted
Amsterdam UMC Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsCompleted
Universitair Medisch Centrum Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsCompleted
Radboud universitair medisch centrum Stichting
Coordinator of this site? Confirm its status
NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsCompleted
Stichting Elisabeth-TweeSteden Ziekenhuis
Coordinator of this site? Confirm its status
TilburgNetherlandsCompleted
Universitair Medisch Centrum Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.