Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled Trial of Pentoxifylline to Improve Endothelial Function in HIV-Infected Patients Not Requiring Antiretroviral Therapy|
- Change in Flow-mediated Dilation of the Brachial Artery [ Time Frame: Measured at baseline and Week 8 ] [ Designated as safety issue: No ]Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.
- Immunologic Parameters (i.e., Activated CD8 Cell Percentage, CD4 Cell Count) [ Time Frame: Measured at baseline and Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Inflammatory Biomarkers (i.e., MCP-1, sVCAM-1, IP-10, MMP-9, TIMP-1, PAI-1 Active, hsCRP) [ Time Frame: Measured at baseline and Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Metabolics (i.e., Fasting Lipid Profile, Glucose, Insulin) [ Time Frame: Measured at baseline and Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: Measured at Weeks 4 and 8 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|