Pentoxifylline and Combination Antiretroviral Therapy to Improve Blood Vessel Function in HIV-Infected People
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|ClinicalTrials.gov Identifier: NCT00864916|
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : April 16, 2014
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Vascular Diseases Cardiovascular Diseases Atherosclerosis HIV Infections||Drug: Combination antiretroviral therapy (cART) 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. This may be due to increased inflammation of the blood vessels, which is often observed in HIV-infected people and which can lead to endothelial dysfunction—a condition that involves the malfunctioning of the thin layer of cells that line the interior surface of blood vessels. Endothelial dysfunction increases the risk of developing both atherosclerosis and cardiovascular disease.
Much of the focus on the causes of HIV-related endothelial dysfunction has been centered on the use of several types of antiretroviral medications used to treat HIV infection. However, more recent data suggest that newer protease inhibitors, a type of antiretroviral medication, are not associated with endothelial dysfunction and that newer combination antiretroviral therapy (cART) regimens result in an initial improvement in endothelial dysfunction. Yet, preliminary research has also shown that in people who receive cART, the risk of endothelial dysfunction in fact persists with time, suggesting that a mechanism other than viral control, notably inflammation, is playing a role in endothelial dysfunction. 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 improve blood vessel function and reduce inflammation in people infected with HIV, but more research is needed to confirm these benefits. The purpose of this study is to compare the safety and effectiveness of pentoxifylline and cART versus cART alone at improving endothelial function and reducing inflammation in HIV-infected people.
This study will enroll people infected with HIV who are about to start receiving cART. At a baseline study visit, participants will undergo a medical history review; physical examination; measurements of blood pressure, heart rate, height, weight, temperature, 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 48 weeks. All participants will also receive cART medications, as prescribed by their primary HIV doctor. At study visits at Weeks 4, 8, 16, 24, 32, and 48, participants will undergo repeat baseline measurements; however, the ultrasound testing will only occur at Weeks 8, 24, and 48.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled Trial of Pentoxifylline Plus Combination ART vs. Combination ART Alone to Improve Endothelial Dysfunction in HIV-Infected Patients|
|Study Start Date :||March 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Participants will receive pentoxifylline and combination antiretroviral therapy (cART).
Drug: Combination antiretroviral therapy (cART)
Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)Drug: Pentoxifylline
Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.
Active Comparator: 2
Participants will receive placebo and cART.
Drug: Combination antiretroviral therapy (cART)
Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)Drug: Placebo
Participants will receive placebo three times per day for 48 weeks.
- Flow-mediated Dilation of the Brachial Artery [ Time Frame: Measured at Week 48 ]Flow-mediated dilation (% dilation of the brachial artery) at week 48
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): NCT00864916
|United States, Indiana|
|Infectious Diseases Research Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Samir K. Gupta, MD, MS||Indiana University School of Medicine|