Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00918073
First received: June 9, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

We will conduct a sub-study of "An Innovative Telephone Intervention for HIV+ Smokers," (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized, prospective trial that will evaluate a cellular phone delivered counseling intervention versus standard of care for smoking cessation. In our sub-study, we will evaluate rates of progression in atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT in those who quit smoking versus those who continue smoking, based on race, sex, state of HIV disease, comorbid diseases, and lipid profile.


Condition
HIV Infections
Smokers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Infected Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • The primary endpoint will compare change in mean maximum carotid IMT over the course of the study between HIV patients who quit smoking and those that continue to smoke. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoint will evaluate change in mean carotid IMT. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV positive smokers
50 HIV infected patients who enroll in a parent protocol to quit smoking and elect to participate in this sub-study.

Detailed Description:

HIV/AIDS patients may have an increased risk of myocardial infarction. Traditional risk factors for coronary artery disease, including cigarette smoking, likely play a large role. The prevalence of smoking in the HIV patient population is higher than the general population. We will conduct a sub-study of "An Innovative Telephone Intervention for HIV+ Smokers," (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized prospective trial that will evaluate a cellular phone delivered counseling intervention versus standard of care for smoking cessation. In our sub-study, we will evaluate rates of progression in atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT in those who quit smoking versus those who continue smoking based on race, sex, state of HIV disease, comorbid diseases and lipid profile. The central hypothesis is that smoking cessation win slow the atherosclerosis progression in HIV patients. A successful behavioral intervention is being evaluated in the parent study. The goal of this sub-study is to assess the effect of a modifiable coronary artery disease risk factor, smoking, in HIV/AIDS patients through this collaboration of cardiovascular expertise and metrics.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV positive smokers who enroll in a smoking cessation trial who elect to participate in this substudy

Criteria

Inclusion Criteria:

  • Patients who meet eligibility criteria for "An innovative telephone intervention for HIV-positive smokers".
  • Patients who consent to the sub-study.
  • Patients who are able to participate in the study for 3 years.

Exclusion Criteria:

  • Patients with a history of coronary bypass surgery, percutaneous coronary intervention, valve replacement, pacemaker or defibrillator implantation.
  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: NCT00918073

Locations
United States, Texas
Thomas Street Health Center
Houston, Texas, United States, 77009
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Tanvir K Bell, MD UT Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Tanvir K. Bell, MD, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00918073     History of Changes
Other Study ID Numbers: UT-GCRC CIMT HIV smokers
Study First Received: June 9, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
HIV infected smokers
HIV

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

ClinicalTrials.gov processed this record on July 29, 2014