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NCT00766818 · ClinicalTrials.gov registry record · Phase 1
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00766818 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants.
The verdict
NCT00766818, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).
Interventions
- DRUG Kaletra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00766818
The ClinicalTrials.gov registry entry for NCT00766818 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Kaletra is the first listed.
NCT00766818 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00766818 about?
NCT00766818 is a clinical study titled "The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet". In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase you...
What is the current status of trial NCT00766818?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00766818?
The interventions under investigation include: Kaletra (DRUG).
Who is sponsoring clinical trial NCT00766818?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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