Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
NCT ID: NCT00050908
Last Updated: 2013-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2007-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able and willing to give written informed consent and to report current smoking status.
* Men who have been on stable testosterone replacement for at least 3 months prior to entry and plan to continue to receive a stable dose during the substudy may enroll. Men who have discontinued testosterone therapy must be off for at least 3 months to be eligible.
* Women receiving oral contraceptives, hormone replacement, or progestational derivatives must have been on stable regimens for at least 3 months prior to enrollment and must plan to remain on the same dose for the duration of the study. Women who have discontinued such therapy must be off for at least 3 months to be eligible.
Exclusion Criteria
* Diabetes mellitus, with the exception of a previous history of gestational or steroid-induced diabetes mellitus within 12 weeks prior to substudy entry.
* Insulin-sensitizing agents such as metformin, pioglitazone, and rosiglitazone.
* Lipid-lowering drugs within 6 weeks prior to substudy entry.
* Systemic glucocorticoids, long-acting inhaled steroids, and certain anabolic steroids within 30 days prior to substudy entry.
* Uncontrolled hypertension.
* Heavy use of vitamin supplements.
13 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Francesca J. Torriani, M.D.
Role: STUDY_CHAIR
University of California, San Diego
Locations
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UCLA School of Med
Los Angeles, California, United States
Univ of California, San Diego Antiviral Research Ctr
San Diego, California, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Northwestern Univ
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, United States
Wishard Hosp
Indianapolis, Indiana, United States
Chelsea Clinic
New York, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Countries
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References
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Stein JH, Klein MA, Bellehumeur JL, McBride PE, Wiebe DA, Otvos JD, Sosman JM. Use of human immunodeficiency virus-1 protease inhibitors is associated with atherogenic lipoprotein changes and endothelial dysfunction. Circulation. 2001 Jul 17;104(3):257-62. doi: 10.1161/01.cir.104.3.257.
Behrens G, Schmidt H, Meyer D, Stoll M, Schmidt RE. Vascular complications associated with use of HIV protease inhibitors. Lancet. 1998 Jun 27;351(9120):1958. doi: 10.1016/S0140-6736(98)26026-0. No abstract available.
Cleland SJ, Sattar N, Petrie JR, Forouhi NG, Elliott HL, Connell JM. Endothelial dysfunction as a possible link between C-reactive protein levels and cardiovascular disease. Clin Sci (Lond). 2000 May;98(5):531-5.
Henderson A. Endothelial dysfunction: a reversible clinical measure of atherogenic susceptibility and cardiovascular inefficiency. Int J Cardiol. 1997 Dec 1;62 Suppl 1:S43-8. doi: 10.1016/s0167-5273(97)00212-x. No abstract available.
Wolf K, Tsakiris DA, Weber R, Erb P, Battegay M; Swiss HIV Cohort Study. Antiretroviral therapy reduces markers of endothelial and coagulation activation in patients infected with human immunodeficiency virus type 1. J Infect Dis. 2002 Feb 15;185(4):456-62. doi: 10.1086/338572. Epub 2002 Jan 18.
Stein JH, Komarow L, Cotter BR, Currier JS, Dube MP, Fichtenbaum CJ, Gerschenson M, Mitchell CK, Murphy RL, Squires K, Parker RA, Torriani FJ; ACTG 5152s Study Team. Lipoprotein Changes in HIV-Infected Antiretroviral-Naive Individuals after Starting Antiretroviral Therapy: ACTG Study A5152s Stein: Lipoprotein Changes on Antiretroviral Therapy. J Clin Lipidol. 2008 Dec;2(6):464-471. doi: 10.1016/j.jacl.2008.08.442.
Other Identifiers
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ACTG A5152s
Identifier Type: -
Identifier Source: secondary_id
10812
Identifier Type: REGISTRY
Identifier Source: secondary_id
A5152s
Identifier Type: -
Identifier Source: org_study_id
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