Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications
|ClinicalTrials.gov Identifier: NCT00796822|
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : May 17, 2013
Last Update Posted : November 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Cardiovascular Diseases Atherosclerosis||Drug: Pentoxifylline Drug: Placebo||Phase 2|
People infected with HIV have an increased risk for cardiovascular disease, which is a leading cause of death for those with HIV. The increase in cardiovascular disease has been thought to be linked to the use of several types of antiretroviral medications used to treat HIV infection. These medications have been shown to cause insulin resistance and dyslipidemia, or high cholesterol levels—conditions that can lead to atherosclerosis, which is a build-up of plaque within the arteries, and ultimately to cardiovascular disease. However, new research is emerging that suggests that people infected with HIV who do not receive antiretroviral medications may also have an increased risk of cardiovascular disease as a result of increased endothelial dysfunction. This condition, which involves malfunctioning of the thin layer of cells that line the interior surface of blood vessels, can lead to atherosclerosis and cardiovascular disease. Pentoxifylline is a medication that is currently used to reduce leg pain in people with blockages in the blood vessels in their legs. Previous research has shown that pentoxifylline may reduce inflammation and improve blood vessel function in people infected with HIV, but more research is needed to confirm these benefits. The purpose of this study is to determine whether pentoxifylline reduces inflammation and improves endothelial function in HIV-infected people who are not receiving antiretroviral medications.
This study will enroll HIV-infected people who are not currently receiving antiretroviral medications. At a baseline study visit, participants will undergo a medical history review; physical examination; measurements in blood pressure, heart rate, height, weight, waist, and hip; and blood and urine collection. An ultrasound imaging test of the arm will measure blood vessel function. Participants will then be randomly assigned to receive either pentoxifylline or placebo three times a day for 8 weeks. At study visits at Weeks 4 and 8, participants will undergo repeat baseline measurements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled Trial of Pentoxifylline to Improve Endothelial Function in HIV-Infected Patients Not Requiring Antiretroviral Therapy|
|Study Start Date :||January 2009|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Participants will receive pentoxifylline.
400 mg three times a day for 8 weeks
Placebo Comparator: 2
Participants will receive placebo.
One pill three times a day for 8 weeks
- Change in Flow-mediated Dilation of the Brachial Artery [ Time Frame: Measured at baseline and Week 8 ]Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.
- Change in Soluble TNF-Receptor I Levels [ Time Frame: Measured at baseline and Week 8 ]Measure of systemic inflammation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796822
|United States, Indiana|
|Indiana Clinical Research Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Samir K. Gupta, MD, MS||Indiana University School of Medicine|