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NCT00630734 · ClinicalTrials.gov registry record · Phase 4

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

A Phase 4 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
32
Enrollment target

NCT00630734 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 32 participants.

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The verdict

NCT00630734, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
32 participants
Enrollment target

Study Summary

Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.

Interventions

  • DRUG Ritonavir
  • DRUG Pravastatin
  • DRUG Darunavir
  • OTHER Washout

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2008-02
Est. Completion 2010-09
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT00630734

The ClinicalTrials.gov registry entry for NCT00630734 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.

NCT00630734 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00630734 about?

NCT00630734 is a clinical study titled "Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin". Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, the...

What is the current status of trial NCT00630734?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2008-02. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00630734?

The interventions under investigation include: Ritonavir (DRUG), Pravastatin (DRUG), Darunavir (DRUG), Washout (OTHER).

Who is sponsoring clinical trial NCT00630734?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.