Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People
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|ClinicalTrials.gov Identifier: NCT00919724|
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : June 30, 2014
Last Update Posted : July 15, 2014
|Condition or disease|
Normally the insides of blood vessels either widen or narrow in response to the need for more or less blood flow. This is a function of the endothelial cells, which are the cells that line the inner layer of blood vessels. However, in some people endothelial function is impaired, which may put them at an increased risk of heart disease and stroke. It is widely assumed that HIV-infected people not yet receiving antiretroviral medications experience more impaired endothelial function than HIV-uninfected people, possibly because of the link between HIV and inflammation. However, no rigorously controlled study has yet to be performed to verify this presumption. It is important to establish whether HIV infection itself, and not the use of antiretroviral medications, is indeed the cause of impaired endothelial function. This study will compare endothelial function in people with HIV who are not already receiving antiretroviral medications and in people without HIV. Specifically, inflammation, immune activation, endothelial activation, and metabolic measures will be compared.
This study will involve two groups of participants. The first group will consist of people with HIV who are enrolling in two other separate HIV studies (NCT00864916 and NCT00796822), one lasting 8 weeks and the other lasting 48 weeks. The second group will consist of people without HIV who are similar to the first group in terms of age, sex, smoking status, and height. All HIV-infected participants will undergo assessments during the study visits of whichever other HIV study they are enrolled in. All HIV-uninfected participants will attend a main study visit that will include the following: a review of medical records and family medical history; measurements of blood pressure, heart rate, weight, temperature, and waist and hip circumferences; blood and urine collection; and a procedure called brachial artery reactivity testing, which is a noninvasive way to measure endothelial function. Some of the HIV-uninfected participants will continue in the study so that any changes in their endothelial function can be assessed. They will attend either two additional study visits at Weeks 4 and 8, which will correspond with one of the HIV studies, or three additional study visits at Weeks 8, 24, and 48, which will correspond with the other HIV study. The additional visits will include repeat testing except for blood and urine collection.
|Study Type :||Observational|
|Actual Enrollment :||89 participants|
|Observational Model:||Case Control|
|Official Title:||A Comparison of Endothelial Function Between HIV-infected Subjects Not Receiving Antiretroviral Therapy and Matched HIV-uninfected Control Subjects|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||May 2013|
HIV-infected participants who are not currently receiving antiretroviral medications
HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
- Endothelial Function (Brachial Artery Reactivity) [ Time Frame: Single measurement ]The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919724
|United States, Indiana|
|Infectious Diseases Research Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Samir K. Gupta, MD, MS||Indiana University School of Medicine|