Clinical trial NCT00864916
Conditions: HIV Vascular Diseases Cardiovascular Diseases Atherosclerosis HIV Infections
Keywords: Endothelial Function Pentoxifylline Antiretroviral Therapy Inflammation
Sponsor: Indiana University
Start date: 2009-03-01; Completion date: 2012-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
People infected with HIV have a greater risk of developing cardiovascular disease than people not infected with HIV. This may be due to increased inflammation in the blood vessels. This study will determine whether an anti-inflammatory drug, pentoxifylline, in combination with antiretroviral medications, is more effective at improving blood vessel function and reducing inflammation than antiretroviral medications alone in people infected with HIV.

Detailed description:
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.

Arms: arm 1: Participants will receive pentoxifylline and combination antiretroviral therapy (cART). arm 2: Participants will receive placebo and cART.
Interventions: intervention 1: Combination antiretroviral therapy (cART) intervention 2: Pentoxifylline intervention 3: Placebo
Intervention descriptions: intervention 1: 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.) intervention 2: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks. intervention 3: Participants will receive placebo three times per day for 48 weeks.

Protocol documents: