Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Public ClinicalTrials.gov record NCT01426438. 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
Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects With Low HDL Cholesterol: A Phase II Randomized Trial of Extended Release Niacin vs. Fenofibrate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C is a type of "good" cholesterol. People with low HDL-C have a higher risk of heart disease and may have problems with how their blood vessels relax. The endothelium is the inner lining of all blood vessels, such as arteries and veins. When the endothelium is not working properly, the blood vessels have trouble expanding properly, which contributes to the development of heart and blood vessel disease. The main purpose of this study is to see if taking either extended-release niacin or fenofibrate for 24 weeks will help blood vessels work better by improving endothelial function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This study will also help determine how safe extended-release niacin and fenofibrate are. The analysis is an as-treated analysis of participants who completed study treatment and had a week 24 BART scan. Safety analyses include all participants
Study identification
- NCT ID
- NCT01426438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 99 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
- Oct 31, 2011
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Feb 2, 2016
2011 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS (5801) | Birmingham | Alabama | 35294 | — |
| University of Southern California (1201) | Los Angeles | California | 90033-1079 | — |
| UCLA CARE Center CRS (601) | Los Angeles | California | 90095 | — |
| Harbor-UCLA Med. Ctr. CRS (603) | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | — |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | — |
| New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477) | Newark | New Jersey | 07103 | — |
| NY Univ. HIV/AIDS CRS (401) | New York | New York | 10016 | — |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27516 | — |
| Duke Univ. Med. Ctr. Adult CRS (1601) | Durham | North Carolina | 27710 | — |
| Moses H. Cone Memorial Hospital CRS (3203) | Greensboro | North Carolina | 27401 | — |
| Univ. of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | — |
| Case CRS (2501) | Cleveland | Ohio | 44106 | — |
| University of Washington AIDS CRS (1401) | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01426438, 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 Feb 2, 2016 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01426438 live on ClinicalTrials.gov.