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NCT00050180 · ClinicalTrials.gov registry record · Phase 4
Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers
A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT00050180 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 81 participants.
The verdict
NCT00050180, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV. If blood levels of these drugs are too low or too high, they may not work well or may cause side effects in patients. This study will determine how MDR1 genes might affect absorption of these medicines. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates will be screened with a medical history and blood and urine tests. The blood will be tested for: * Routine laboratory values for assessing general health * HIV * MDR1 gene type * Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells. Participants will have blood drawn three more times, as follows: * After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single blood sample will be drawn through a needle in an arm vein. This part of the study will assess the efficiency of a certain enzyme involved in metabolizing (breaking down) indinavir and saquinavir. * After four doses of indinavir: About a week after taking the midazolam, participants will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day. The following morning they will come to the clinic, where a catheter (flexible plastic tube) will be placed in an arm vein for repeated blood draws. A blood sample will be drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of about a teaspoon each will then be collected through the catheter over an 8-hour period to measure blood levels of the drug. * After 10 doses of saquinavir: About a week after the last dose of indinavir, participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules 3 times a day for 3 days. On the fourth day, participants will come to the clinic. A ca
Interventions
- DRUG Midazolam
- DRUG Saquinavir
- DRUG Indinavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2002-11-22 |
| Est. Completion | 2007-08-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050180
The ClinicalTrials.gov registry entry for NCT00050180 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT00050180 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00050180 about?
NCT00050180 is a clinical study titled "Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers". This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV. If blood levels of these drugs are too low or too high, they may not work well or may cause side effects...
What is the current status of trial NCT00050180?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2002-11-22. Estimated completion is 2007-08-24.
What interventions are being tested in trial NCT00050180?
The interventions under investigation include: Midazolam (DRUG), Saquinavir (DRUG), Indinavir (DRUG).
Who is sponsoring clinical trial NCT00050180?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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