Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
Public ClinicalTrials.gov record NCT00006412. 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 Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood. Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. The drugs used in this study are known to reduce certain lipids, but little is known about their safety and effectiveness. This study will see if one of the drugs is safer and more effective than the other, or if combining the drugs is the safest and most effective way to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the progress of the study. The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals. There were no safety concerns. It is not known if the combination of fenofibrate and pravastatin is effective and safe. Therefore, it is important to continue this study.
Study identification
- NCT ID
- NCT00006412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 630 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
- Not listed
- Primary completion
- Not listed
- Completion
- Apr 30, 2003
- Last update posted
- Oct 31, 2021
Ends 2003
United States locations
- U.S. sites
- 57
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | — |
| UCLA CARE Ctr | Los Angeles | California | 90095 | — |
| Willow Clinic | Menlo Park | California | 94025 | — |
| Univ of California, San Diego | San Diego | California | 92103 | — |
| University of California San Francisco | San Francisco | California | 941104206 | — |
| Univ of California San Francisco | San Francisco | California | 94110 | — |
| San Mateo AIDS Program / Stanford Univ | Stanford | California | 943055107 | — |
| Stanford Univ Med Ctr | Stanford | California | 943055107 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Denver Dept of Health and Hosps | Denver | Colorado | 80262 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Emory Univ | Atlanta | Georgia | 30308 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Tripler Army Med Ctr | Tripler AMC | Hawaii | 96859 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| The CORE Ctr | Chicago | Illinois | 60612 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Methodist Hosp of Indiana / Life Care Clinic | Indianapolis | Indiana | 46202 | — |
| Wishard Hosp | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| Brigham and Women's Hosp | Boston | Massachusetts | 02215 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Univ of Nebraska Med Ctr | Omaha | Nebraska | 681985130 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| Beth Israel Med Ctr | New York | New York | 10003 | — |
| Cornell Clinical Trials Unit - Chelsea Clinic | New York | New York | 10011 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Cornell Univ Med Ctr | New York | New York | 10021 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Community Health Network Inc | Rochester | New York | 14642 | — |
| St Mary's Hosp (Univ of Rochester/Infectious Diseases) | Rochester | New York | 14642 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas Med Ctr | Charlotte | North Carolina | 28203 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Moses H Cone Memorial Hosp | Greensboro | North Carolina | 27401 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| MetroHealth Med Ctr | Cleveland | Ohio | 441091998 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Philadelphia Veterans Administration Med Ctr | Philadelphia | Pennsylvania | 19104 | — |
| Univ of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hosp / Brown Univ | Providence | Rhode Island | 02903 | — |
| Brown Univ / Miriam Hosp | Providence | Rhode Island | 02906 | — |
| Miriam Hosp / Brown Univ | Providence | Rhode Island | 02906 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 37203 | — |
| Univ of Texas, Southwestern Med Ctr of Dallas | Dallas | Texas | 75390 | — |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | — |
| Univ of Washington | 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 NCT00006412, 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 Oct 31, 2021 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006412 live on ClinicalTrials.gov.