Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients
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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 |
- 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 ]
- 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 |
HIV positive smokers who enroll in a smoking cessation trial who elect to participate in this substudy
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| United States, Texas | |
| Thomas Street Health Center | |
| Houston, Texas, United States, 77009 | |
| 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 May 21, 2013