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NCT00054743 · ClinicalTrials.gov registry record · Phase 4
Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States
A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00054743 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 24 participants.
The verdict
NCT00054743, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will determine whether blood levels of the anti-HIV medicine nevirapine are different in HIV-infected patients in the United States from patients in Uganda. People from all over the world take medications to treat HIV infection. These medicines work well in some people but not in others, and they cause harmful side effects in some people and not in others. These differences may be related to variations in how much of the drug reaches the blood. Differences in drug blood levels among people in various areas of the world may be attributed to differences in diet, state of health, ability to absorb the medicines from the stomach, ability to eliminate the drugs from the body, and the brand of medicine taken. This study will help scientists learn whether differences in blood levels of HIV medicines are important in determining how well the drugs work in different patient populations. HIV-infected patients 18 years of age and older in the United States and in Kampala, Uganda who have been on an antiretroviral treatment regimen that includes at least 28 consecutive days of nevirapine may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests. Participants will have a total of approximately about 5 ounces of blood drawn during this 6- to 8-hour study. They will come to the NIH clinic in the morning, and a catheter (plastic tube) will be inserted into an arm vein for collecting blood. (Alternatively, blood can be collected by a needle inserted into an arm vein.) Blood will be withdrawn according to the following schedule: * About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast. Within 30 minutes of this blood draw, the patient will have breakfast and take his or her morning dose of nevirapine, along with any other medications that need to be taken at that time. * 1 tablespoon of blood will be drawn 2 hours after the nevirapine dose. * 1 tablespoon of blood will be d
Interventions
- PROCEDURE Blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-02-06 |
| Est. Completion | 2011-04-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00054743
The ClinicalTrials.gov registry entry for NCT00054743 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 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 1 intervention - of which Blood draw is the first listed.
NCT00054743 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00054743 about?
NCT00054743 is a clinical study titled "Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States". This study will determine whether blood levels of the anti-HIV medicine nevirapine are different in HIV-infected patients in the United States from patients in Uganda. People from all over the world take medications to treat HIV infection. These medicines work well in some people but not in others, ...
What is the current status of trial NCT00054743?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2003-02-06. Estimated completion is 2011-04-28.
What interventions are being tested in trial NCT00054743?
The interventions under investigation include: Blood draw (PROCEDURE).
Who is sponsoring clinical trial NCT00054743?
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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