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

July 26, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1793
        • UCLA School of Med
      • San Diego, California, United States, 92103
        • Univ of California, San Diego Antiviral Research Ctr
    • Hawaii
      • Honolulu, Hawaii, United States, 96816-2396
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 46202
        • Northwestern Univ
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Hosp
      • Indianapolis, Indiana, United States, 46202-5250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, United States, 46202-5250
        • Methodist Hosp of Indiana
    • New York
      • New York, New York, United States, 10011
        • Chelsea Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 43210-1282
        • Univ of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Chair: Francesca J. Torriani, M.D., University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 30, 2002

First Submitted That Met QC Criteria

December 31, 2002

First Posted (Estimate)

January 1, 2003

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5152s
  • ACTG A5152s
  • 10812 (DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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