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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00050908
Recruitment Status : Completed
First Posted : January 1, 2003
Last Update Posted : July 29, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infections

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 Design

Study Type : Observational
Estimated Enrollment : 75 participants
Time Perspective: Prospective
Official Title: Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050908

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)
Study Chair: Francesca J. Torriani, M.D. University of California, San Diego
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00050908     History of Changes
Other Study ID Numbers: A5152s
ACTG A5152s
10812 ( Registry Identifier: DAIDS ES )
First Posted: January 1, 2003    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Brachial Artery
Endothelium, Vascular
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Drug Therapy, Combination
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases