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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00796822 |
Patients with HIV infection have an increased risk of cardiovascular disease compared to non-HIV-infected persons. Increased inflammation in the body may be responsible for the increased rate of heart attacks and strokes in HIV-infected patients. We will assess if the anti-inflammatory drug pentoxifylline improves vascular function in HIV-infected patients in a controlled trial.
Condition | Intervention | Phase |
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HIV |
Drug: Pentoxifylline Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Trial of Pentoxifylline to Improve Endothelial Function in HIV-Infected Patients Not Requiring Antiretroviral Therapy |
Estimated Enrollment: | 26 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pentoxifylline: Experimental
400mg orally thrice daily
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Drug: Pentoxifylline
400mg orally thrice daily
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Sugar pill: Placebo Comparator |
Drug: Placebo
one pill orally thrice daily
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With the reduction in mortality due to combination antiretroviral therapy (cART), cardiovascular disease has emerged as a leading cause of death in HIV-infected patients. Because several antiretrovirals cause insulin resistance and dyslipidemia, the increased risk for atherosclerotic disease has been attributed primarily to these drugs. However, evidence is emerging that suggest untreated HIV infection contributes significantly to the risk for future cardiovascular events. Inflammation and endothelial cell dysfunction are key promoters of atherosclerosis in the general population. Vascular lesions in HIV-infected patients demonstrate increased leukocyte adhesion to the endothelium with elevated levels of monocyte chemoattractant protein-1 (MCP-1) and vascular cell adhesion molecule-1 (VCAM-1). In cART-naïve patients, levels of these adhesion molecules are increased and endothelial dysfunction is common. cART only partly reduces levels of these molecules and only partly restores endothelial function. Our novel preliminary data suggest that the anti-inflammatory drug pentoxifylline (PTX) may significantly improve flow-mediated dilation of the brachial artery, an in vivo measure of endothelial function, in HIV-infected subjects by inhibiting leukocyte recruitment and adhesion.
We will determine if PTX truly improves flow-mediated dilation of the brachial artery in a randomized, placebo-controlled trial. We will enroll a total of 26 HIV-infected patients not requiring antiretroviral treatment and randomize them to either receiving PTX (400mg thrice daily) or to matching placebo for a total of 8 weeks. Flow-mediated dilation will be measured at entry, at week 4, and at week 8. Biomarkers of inflammation, coagulation, and endothelial activation will also be measured at these time points.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: There is no HIV-1 RNA level eligibility criterion.
Exclusion Criteria:
Note: Hepatitis B or C co-infections are NOT exclusionary
Note: History of gestational diabetes is not exclusionary if the potential subject does not have current ADA-defined diabetes.
Note: Use of caffeinated products, except on the mornings of the study visits, is not exclusionary.
Note: Fever within 48 hours prior to each main study visit will require postponement of that study visit until the patient has defervesced (T < 38.0C) for at least 48 hours; fevers continuing past the allowed study visit timeframe will result in study discontinuation.
-Therapy for acute infection or other serious medical illnesses within 14 days prior to screening.
Note: Therapy for acute infection or other serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.
Note: Hypotension noted prior to brachial artery reactivity testing on each main study visit will result in study visit postponement of at least one day until systolic pressure is ≥ 90mmHg the morning of brachial reactivity testing; postponement outside of the allowed study visit timeframe will result in study discontinuation.
Note: Physiologic testosterone replacement therapy is not exclusionary.
Contact: Beth W Zwickl, NP, APN-BC, ACRP | 317-278-8453 | bwzwickl@iupui.edu |
Contact: Maria Boston, RN | 317-278-8841 | mboston@iupui.edu |
United States, Indiana | |
Indiana Clinical Research Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Samir K Gupta, MD, MS | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Samir Kumar Gupta, MD ) |
Study ID Numbers: | 614, R01 HL095149-01 |
Study First Received: | November 21, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00796822 |
Health Authority: | United States: Federal Government |
HIV, Endothelial function, inflammation |
HIV Infections Acquired Immunodeficiency Syndrome Pentoxifylline Inflammation |
Radiation-Protective Agents Vasodilator Agents Antioxidants Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Therapeutic Uses Free Radical Scavengers Platelet Aggregation Inhibitors |