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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00050908 |
This is a substudy of ACTG A5142. The purpose of this substudy is to evaluate blood vessel function in HIV-infected patients taking anti-HIV drugs.
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen |
Estimated Enrollment: | 75 |
Endothelial dysfunction, assessed by measurement of brachial artery reactivity, is associated with coronary artery disease. Previous studies showed that patients taking HIV protease inhibitors (PIs) had a buildup of fatty deposits in their arteries and impaired flow-mediated vasodilation of the brachial artery, whereas endothelial function was normal in HIV-infected individuals not taking PIs. The effect of three different antiretroviral regimens on endothelial function in antiretroviral naïve HIV-infected patients will be examined in this substudy.
Patients in this substudy will have Brachial Artery Reactivity Tests (BARTs), which are painless ultrasound tests of an artery in the lower arm. Brachial artery reactivity will be measured at entry and at 4 and 24 weeks after patients are randomized to one of three open-label drug regimens in ACTG A5142. Brachial artery reactivity in response to two vasoactive stimuli (flow-mediated and nitroglycerin) will be assessed by measuring brachial artery diameter and flow velocity. Blood will be drawn at Weeks 4 and 24 for insulin and lipid tests. Patients will fast and refrain from tobacco and caffeine use for at least 8 hours prior to each study visit. For the duration of the substudy, patients will be asked not to change the amount of fruits, juices, antioxidants, and tea that they consume.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA School of Med | |
Los Angeles, California, United States, 90095-1793 | |
Univ of California, San Diego Antiviral Research Ctr | |
San Diego, California, United States, 92103 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816-2396 | |
United States, Illinois | |
Northwestern Univ | |
Chicago, Illinois, United States, 46202 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 46202-5250 | |
Methodist Hosp of Indiana | |
Indianapolis, Indiana, United States, 46202-5250 | |
Wishard Hosp | |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
Chelsea Clinic | |
New York, New York, United States, 10011 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 43210-1282 |
Study Chair: | Francesca J. Torriani, M.D. | University of California, San Diego |
Study ID Numbers: | ACTG A5152s |
Study First Received: | December 30, 2002 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00050908 |
Health Authority: | United States: Federal Government |
Brachial Artery Endothelium, Vascular Vasodilation Nitroglycerin Reverse Transcriptase Inhibitors HIV Protease Inhibitors Drug Therapy, Combination |
Ritonavir efavirenz lopinavir stavudine lamivudine zidovudine Treatment Naive |
Efavirenz Sexually Transmitted Diseases, Viral Stavudine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes |
Nitroglycerin Virus Diseases Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |