NCT00825929 Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
| NCT ID | NCT00825929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 176 participants |
| Start Date | 2009-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 176 participants in total. It began in 2009-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
David M Burger, PharmD PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Centre Nijmegen
Frequently Asked Questions
Who can join the NCT00825929 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00825929 currently recruiting?
Yes, NCT00825929 is actively recruiting participants. Contact the research team at david.burger@radboudumc.nl for enrollment information.
Where is the NCT00825929 trial being conducted?
This trial is being conducted at Brussels, Belgium, Berlin, Germany, Bonn, Germany, Cologne, Germany and 11 additional locations.
Who is sponsoring the NCT00825929 clinical trial?
NCT00825929 is sponsored by Radboud University Medical Center. The principal investigator is David M Burger, PharmD PhD at Radboud University Medical Centre Nijmegen. The trial plans to enroll 176 participants.
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