Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
Public ClinicalTrials.gov record NCT00041769. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized Controlled Trial Evaluating the Impact of Therapeutic Drug Monitoring (TDM) on Virologic Response to a Salvage Regimen in Subjects With a Normalized Inhibitory Quotient (NIQ) Less Than or Equal to 1 to One or More Protease Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00041769
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 360 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2002 (Type not available)
- Primary completion
- Apr 2007 (Actual)
- Completion
- Aug 2007 (Actual)
- Last update posted
- Jul 13, 2010
2002 – 2007
United States locations
- U.S. sites
- 46
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35924-2050 | — |
| Univ of Southern California | Los Angeles | California | 90033-1079 | — |
| UCLA School of Medicine | Los Angeles | California | 90095 | — |
| Univ of California, San Diego Antiviral Research Center (AVRC) | San Diego | California | 92103 | — |
| Univ of California San Francisco | San Francisco | California | 94110 | — |
| San Mateo County AIDS Program | Stanford | California | 94305-5107 | — |
| Santa Clara Valley Med Ctr | Stanford | California | 94305-5107 | — |
| Willow Clinic | Stanford | California | 94305-5107 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Univ of Miami | Miami | Florida | 33136-1013 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816-2396 | — |
| Northwestern Univ | Chicago | Illinois | 60611-3015 | — |
| The CORE Ctr | Chicago | Illinois | 60612 | — |
| Methodist Hosp of Indiana | Indianapolis | Indiana | 46202-1261 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 46202-5250 | — |
| Wishard Hosp | Indianapolis | Indiana | 46202 | — |
| Univ of Maryland, Institute of Human Virology | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Univ | Baltimore | Maryland | 21287-8106 | — |
| Harvard (Masschusetts General Hosp) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess-West Campus | Boston | Massachusetts | 02215 | — |
| Brigham and Women's Hosp | Boston | Massachusetts | 02215 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455-0392 | — |
| St. Louis Connect Care | St Louis | Missouri | 63108-2138 | — |
| Washington Univ (St. Louis) | St Louis | Missouri | 63108-2138 | — |
| SUNY-Buffalo (Rochester) | Buffalo | New York | 14215 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Chelsea Clinic | New York | New York | 10011 | — |
| New York University - Bellevue | New York | New York | 10016 | — |
| Long Beach Memorial (Pediatric) | New York | New York | 10021 | — |
| Columbia Univ | New York | New York | 10032 | — |
| Community Health Network Inc | Rochester | New York | 14642 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Ohio State Univ | Cincinnati | Ohio | 45267-0405 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 45267-0405 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44109-1998 | — |
| MetroHealth Med Ctr | Cleveland | Ohio | 44109-1998 | — |
| Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hosp | Providence | Rhode Island | 02906 | — |
| Stanley Street Treatment and Resource | Providence | Rhode Island | 02906 | — |
| The Miriam Hosp | Providence | Rhode Island | 02906 | — |
| Comprehensive Care Clinic | Nashville | Tennessee | 37203 | — |
| Univ of Texas, Galveston | Galveston | Texas | 77555-0435 | — |
| Univ of Washington (Seattle) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00041769, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2010 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00041769 live on ClinicalTrials.gov.