Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00050908

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

75

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participation in ACTG A5142 .
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:

Coronary heart disease, peripheral vascular disease, or cerebrovascular disease.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050908

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:

Francesca J. Torriani, M.D.

University of California, San Diego

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

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.

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. 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. Review. No abstract available.

Wolf K, Tsakiris DA, Weber R, Erb P, Battegay M. 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.

Study ID Numbers:	ACTG A5152s
Study First Received:	December 30, 2002
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00050908 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Brachial Artery
Endothelium, Vascular
Vasodilation
Nitroglycerin
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Drug Therapy, Combination

Ritonavir
efavirenz
lopinavir
stavudine
lamivudine
zidovudine
Treatment Naive

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009