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Clinical Trials in Spain / NCT00825929
Recruiting Observational

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

NCT00825929 · tracked via the Priya Life Science Spain tracker
Sponsor
Radboud University Medical Center
Phase
Observational
Started
2009-02
Last updated
2025-01-13

Condition(s) studied

HIV Infections

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test. 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 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. 5. Subject is pregnant 6. Subject is able to adhere to food intake recommendations, if applicable. 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 study and the procedures required. 3. Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL). 4. Using oral cabotegravir/rilpivirine.

Primary outcome measure(s)

  • 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

Trial sites (21)

FacilityCityRegionStatus
Saint-Pierre University Hospital; Department of Infectious Diseases Brussels Belgium Recruiting
CHARITÉ Berlin Berlin Germany Recruiting
University of Bonn Bonn Germany Recruiting
University of Cologne Cologne Germany Recruiting
Johann Wolfgang Goethe-Universität Frankfurt am Main Germany Recruiting
University München München Germany Recruiting
Mater Hospital and UCD Dublin Ireland Recruiting
St James's Hospital Dublin Dublin Ireland Recruiting
IRCSS Rome Italy Completed
AMC Amsterdam Netherlands Completed
Radboud University Nijmegen Medical Centre Nijmegen Netherlands Recruiting
Erasmus Medical Center Rotterdam Rotterdam Netherlands Recruiting
St Elisabeth hospital Tilburg Netherlands Recruiting
Hospital Universitari Germans Trias i Pujol, Badalona Badalona Spain Recruiting
Hospital Universitario Virgen de las Nieves Granada; Médico Adjunto del Servicio de Medicina Interna Granada Spain Recruiting
Brighton and Sussex University Hospitals NHS Trust Brighton United Kingdom Recruiting
C&W Hospital, London London United Kingdom Recruiting
North Middlesex Hospital London United Kingdom Completed
St Mary's Hospital, London London United Kingdom Recruiting
St Thomas Hospital London United Kingdom Withdrawn
St. George's Hospital, London London United Kingdom Completed

More Radboud University Medical Center trials in Spain

A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study Recruiting

Other trials for the same condition

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults Active, not recruiting
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults Active, not recruiting
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) Recruiting
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00825929 on ClinicalTrials.gov ↗ ← All trials in Spain