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NCT00041769 · ClinicalTrials.gov registry record · Phase 3
Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT00041769 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 360 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT00041769, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug and may further increase the benefits that resistance testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the viral load in PI-experienced patients. Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians' interpret their TDM results and adjust their PI doses will have better virologic response rates and decreased toxicities (and thus better treatment outcomes) than participants who do not undergo TDM.
Conditions Studied
Interventions
- PROCEDURE Therapeutic Drug Monitoring (TDM)
Study Locations (20)
California
- Univ of Southern California - Los Angeles
- UCLA School of Medicine - Los Angeles
- Univ of California, San Diego Antiviral Research Center (AVRC) - San Diego
- Univ of California San Francisco - San Francisco
- San Mateo County AIDS Program - Stanford
- Santa Clara Valley Med Ctr - Stanford
- Willow Clinic - Stanford
Indiana
- Methodist Hosp of Indiana - Indianapolis
- Indiana Univ Hosp - Indianapolis
- Wishard Hosp - Indianapolis
Illinois
- Northwestern Univ - Chicago
- The CORE Ctr - Chicago
Maryland
- Univ of Maryland, Institute of Human Virology - Baltimore
- Johns Hopkins Univ - Baltimore
Massachusetts
- Harvard (Masschusetts General Hosp) - Boston
- Beth Israel Deaconess-West Campus - Boston
Alabama
- Univ of Alabama at Birmingham - Birmingham
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Florida
- Univ of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2002-06 |
| Est. Completion | 2007-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00041769
The ClinicalTrials.gov registry entry for NCT00041769 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (19% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Therapeutic Drug Monitoring (TDM) is the first listed.
NCT00041769 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Indiana, Illinois.
Frequently Asked Questions
What is clinical trial NCT00041769 about?
NCT00041769 is a clinical study titled "Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor". Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug a...
What is the current status of trial NCT00041769?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2002-06. Estimated completion is 2007-08.
What conditions does trial NCT00041769 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00041769?
The interventions under investigation include: Therapeutic Drug Monitoring (TDM) (PROCEDURE).
Who is sponsoring clinical trial NCT00041769?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00041769 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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