Investigación sobre la concentración de medicamentos Anti-VIH en la sangre de mujeres embarazadas infectadas por el VIH (Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women, PANNA) - PANNA

Conditions: Infección por el VIH en mujeres embarazadas (HIV-infection in pregnant women)
MedDRA version: 9.1Level: LLTClassification code 10020175Term: HIV infection with other conditions

Registration Number: EUCTR2008-006158-16-ES

Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 192

Inclusion Criteria

1. HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
2. Subject is at least 18 years of age at screening .
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. Treated with an HAART 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.
5. Duration of pregnancy not longer than 33 weeks at the day of screening
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
2. Inability to understand the nature and extent of the trial and the procedures required.
3. Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Plasma concentrations of antiretroviral agents will be measured in all available samples by means of a validated HPLC-UV or LC-MS/MS methods. <br>AUC0-12 or 0-24; Cmax; Cmin, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy. Determination of pharmacokinetic parameters in infants if applicable.;Main Objective: To describe the pharmacokinetics of antiretroviral agents for which no or only limited pharmacokinetic data during pregnancy are available, in the 3rd trimester of pregnant HIV-infected women and at 4-6 weeks post-partum.;Secondary Objective: Determination of pharmacokinetics in the infant in case of post-exposure prophylaxis with one of the agents tested.

Secondary Outcome Measures