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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00050908
First received: December 30, 2002
Last updated: July 26, 2013
Last verified: July 2013
  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: Time Perspective: Prospective
Official Title: Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen

Resource links provided by NLM:


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

Estimated Enrollment: 75
Study Completion Date: May 2007
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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
Study First Received: December 30, 2002
Last Updated: July 26, 2013
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014