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NCT01426438 · ClinicalTrials.gov registry record · Phase 2
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT01426438 is a Phase 2 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 99 participants.
The verdict
NCT01426438, a Phase 2 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Niacin
- DRUG Aspirin
- DRUG Fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01426438
The ClinicalTrials.gov registry entry for NCT01426438 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Niacin is the first listed.
NCT01426438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01426438 about?
NCT01426438 is a clinical study titled "Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate". 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, s...
What is the current status of trial NCT01426438?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2011-11. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01426438?
The interventions under investigation include: Niacin (DRUG), Aspirin (DRUG), Fenofibrate (DRUG).
Who is sponsoring clinical trial NCT01426438?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
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