Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients

HIV Infections Clinical Trial

Official title:

Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918073
• Other study ID #: UT-GCRC CIMT HIV smokers
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: May 6, 2013
• Start date: November 2007
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Smokers

Locations

Country	Name	City	State
United States	Thomas Street Health Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years	No
Secondary	The secondary endpoint will evaluate change in mean carotid IMT.		3 years	No