Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs

NCT00050908 | Completed

• 3 other identifiers: A5152sACTG A5152s10812
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

HIV Infections

Keywords

Brachial Artery; Endothelium, Vascular; Vasodilation; Nitroglycerin; Reverse Transcriptase Inhibitors; HIV Protease Inhibitors; Drug Therapy, Combination; Ritonavir; efavirenz; lopinavir; stavudine; lamivudine; zidovudine; Treatment Naive

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (9)

UCLA School of Med

Los Angeles, California, 90095-1793, United States

Location

Univ of California, San Diego Antiviral Research Ctr

San Diego, California, 92103, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816-2396, United States

Location

Northwestern Univ

Chicago, Illinois, 46202, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 46202-5250, United States

Location

Methodist Hosp of Indiana

Indianapolis, Indiana, 46202-5250, United States

Location

Wishard Hosp

Indianapolis, Indiana, 46202, United States

Location

Chelsea Clinic

New York, New York, 10011, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 43210-1282, United States

Location

Related Publications (6)

• 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.

  PMID: 11457741 BACKGROUND

• 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.

  PMID: 9654284 BACKGROUND

• 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.

  PMID: 10781383 BACKGROUND

• 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.

  PMID: 9464583 BACKGROUND

• 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.

  PMID: 11865397 BACKGROUND

• 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.

  PMID: 19956354 RESULT

MeSH Terms

Conditions

HIV Infections; Aneurysm

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francesca J. Torriani, M.D.

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2002
• First Posted: January 1, 2003
• Study Completion: May 1, 2007
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

US (9)