HIV InfectionsNCT00918073
Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients
An observational study of HIV Infections and Smokers, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections, Smokers
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV positive smokers who enroll in a smoking cessation trial who elect to participate in this substudy
Who may be able to join
- 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.
Who cannot join
- Patients with a history of coronary bypass surgery, percutaneous coronary intervention, valve replacement, pacemaker or defibrillator implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, Smokers
- Keywords
- HIV infected smokers, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive smokers | 50 HIV infected patients who enroll in a parent protocol to quit smoking and elect to participate in this sub-study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
The secondary endpoint will evaluate change in mean carotid IMT.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
- Investigators
- Tanvir K Bell, MD, Principal investigator, UT Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918073
- Sponsor's protocol ID
- UT-GCRC CIMT HIV smokers
- Status last verified
- May 2013
- First submitted
- 9 Jun 2009
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT00918073
- Acronym / sponsor ID
- UT-GCRC CIMT HIV smokers
- Conditions
- HIV Infections, Smokers
- Keywords
- HIV infected smokers, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive smokers | – | –50 HIV infected patients who enroll in a parent protocol to quit smoking and elect to participate in this sub-study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV positive smokers who enroll in a smoking cessation trial who elect to participate in this substudy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a history of coronary bypass surgery, percutaneous coronary intervention, valve replacement, pacemaker or defibrillator implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The secondary endpoint will evaluate change in mean carotid IMT.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanvir K Bell, MD principal investigator
UT Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Smokers, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.