HIV Infections Clinical Trial
— PANNAOfficial title:
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
NCT number | NCT00825929 |
Other study ID # | UMCN-AKF 08.02 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 2009 |
Est. completion date | December 2025 |
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 | Recruiting |
Enrollment | 176 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Saint-Pierre University Hospital; Department of Infectious Diseases | Brussels | |
Germany | CHARITÉ Berlin | Berlin | |
Germany | University of Bonn | Bonn | |
Germany | University of Cologne | Cologne | |
Germany | Johann Wolfgang Goethe-Universität | Frankfurt am Main | |
Germany | University München | München | |
Ireland | Mater Hospital and UCD | Dublin | |
Ireland | St James's Hospital Dublin | Dublin | |
Italy | IRCSS | Rome | |
Netherlands | AMC | Amsterdam | |
Netherlands | Radboud University Nijmegen Medical Centre | Nijmegen | |
Netherlands | Erasmus Medical Center Rotterdam | Rotterdam | |
Netherlands | St Elisabeth hospital | Tilburg | |
Spain | Hospital Universitari Germans Trias i Pujol, Badalona | Badalona | |
Spain | Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna | Granada | |
United Kingdom | Brighton and Sussex University Hospitals NHS Trust | Brighton | |
United Kingdom | C&W Hospital, London | London | |
United Kingdom | North Middlesex Hospital | London | |
United Kingdom | St Mary's Hospital, London | London | |
United Kingdom | St Thomas Hospital | London | |
United Kingdom | St. George's Hospital, London | London |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceutica, Merck Sharp & Dohme LLC, PENTA Foundation, ViiV Healthcare |
Belgium, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom,
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 — View Citation
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. — View Citation
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-infecte — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery | PK curve in Week 33 of pregnancy and 4-6 weeks after delivery | ||
Secondary | Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study. | Week 1, 3 and between 4 and 6 | ||
Secondary | Safety of antiretrovirals during pregnancy | GA Week 33 until end of trial | ||
Secondary | viral load response and prevention of mother to child transmission of the virus | GA Week 3 and at delivery |
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