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

June 9, 2009
May 6, 2013
November 2007
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00918073 on ClinicalTrials.gov Archive Site
The secondary endpoint will evaluate change in mean carotid IMT. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients
Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Infected Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • HIV Infections
  • Smokers
Not Provided
HIV positive smokers
50 HIV infected patients who enroll in a parent protocol to quit smoking and elect to participate in this sub-study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00918073
UT-GCRC CIMT HIV smokers
No
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Tanvir K Bell, MD UT Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP