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NCT00011635 · ClinicalTrials.gov registry record · Phase 1
The Effect of Milk Thistle on the Pharmacokinetics of Indinavir
A Phase 1 study of Healthy and HIV Infection, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00011635 is a Phase 1 study of Healthy and HIV Infection that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00011635, a Phase 1 study of Healthy and HIV Infection, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Complementary and alternative medicines are widely used in the HIV-infected population. Recent data have shown serious drug interactions between certain complementary medicines and protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in HIV-infected patients for treatment of hepatitis or as a hepato-protectant. Data are available suggesting that it may alter cytochrome P4503A4-mediated drug metabolism. To evaluate the effect of milk thistle on the protease inhibitor, indinavir (IDV), ten healthy subjects will receive IDV (Crixivan) alone and in combination with an over-the-counter silymarin preparation. IDV will initially be administered alone at a dose of 800 mg Q8H for four doses and serial samples will be collected for determination of IDV pharmacokinetics after the morning dose on day 2. Subjects will then initiate therapy will milk thistle using a standardized formulation and dose for three weeks after which subjects will then again take 4 doses of IDV and have serial samples collected for IDV plasma concentrations. There will then be a 11-day washout period with no drugs, after which IDV will again be given for 4 doses and samples will be collected evaluate the offset of the effects of milk thistle. To examine the effect of milk thistle on other CYP450 pathways, subjects will receive a single dose of caffeine and dextromethorphan and have urine collected before and after milk thistle, and after the washout period. Indinavir, caffeine, and dextromethorphan concentrations in plasma or urine will be determined using validated HPLC methods. Steady-state noncompartmental parameters of indinavir in the presence and absence of milk thistle will be determined. Pharmacokinetic parameters will be compared using ANOVA that will include factors for a period effect and a treatment effect. Statistical analyses will include calculation of the mean ratio of the AUC in the treatment phases compared to IDV alone and determination of 95% confidence
Conditions Studied
Interventions
- DRUG Silymarin (milk thistle)
Study Locations (1)
Maryland
- Warren G. Magnuson Clinical Center (CC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2001-02 |
| Est. Completion | 2001-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00011635
The ClinicalTrials.gov registry entry for NCT00011635 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Silymarin (milk thistle) is the first listed.
NCT00011635 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00011635 about?
NCT00011635 is a clinical study titled "The Effect of Milk Thistle on the Pharmacokinetics of Indinavir". Complementary and alternative medicines are widely used in the HIV-infected population. Recent data have shown serious drug interactions between certain complementary medicines and protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in HIV-infected patients for treatm...
What is the current status of trial NCT00011635?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2001-02. Estimated completion is 2001-06.
What conditions does trial NCT00011635 study?
This clinical trial studies the following conditions: Healthy, HIV Infection.
What interventions are being tested in trial NCT00011635?
The interventions under investigation include: Silymarin (milk thistle) (DRUG).
Who is sponsoring clinical trial NCT00011635?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00011635 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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