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Completed

NCT Number: NCT00918073

Evaluation of Cardiovascular Effects of Smoking Cessation in HIV 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The secondary endpoint will evaluate change in mean carotid IMT.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Infected Patients

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2009
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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