A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
This research study is to see whether blood vessel function, an early sign of heart disease, improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators will be looking at how a blood vessel in the arm, called the brachial artery, changes in response to stress before and after taking telmisartan. To determine how well the blood vessel functions, the investigators will be using an ultrasound machine.
Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat blood pressure, but has been shown to improve blood vessel function in HIV-negative people with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this trial is sponsored by The Campbell Foundation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease|
- Change in brachial artery flow-mediated dilatation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of telmisartan [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]mean decrement in systolic and diastolic blood pressure, number of subjects experiencing Grade 3 or greater adverse events (and type of adverse event), number of subjects experiencing any event leading to study discontinuation (and type of event), change in serum creatinine
- Change in inflammatory biomarkers on telmisartan [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change in a variety of biomarkers associated with inflammation, monocyte activation, and vascular function.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
80mg tablets po daily for 12 weeks
Other Name: Micardis
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578772
|Contact: Vanessa Cajahuaringafirstname.lastname@example.org|
|United States, California|
|UCLA CARE Center||Recruiting|
|Los Angeles, California, United States, 90035|
|Contact: Kieta Mutepfa, MSW 310-557-9027 KMutepfa@mednet.ucla.edu|
|Principal Investigator:||Jordan E. Lake, MD||University of California, Los Angeles|