Conditions: HIV Infection
Keywords: HIV Cardiovascular Disease Endothelial Dysfunction
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.

Detailed description:
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.

Arms:
arm 1: Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily arm 2: Start antiretroviral therapy (ART) immediately and initiate placebo pill daily arm 3: Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily arm 4: Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily

Interventions: intervention 1: Aspirin 325mg intervention 2: Antiretroviral therapy (ART)
Intervention descriptions: intervention 1: Patients randomized to Aspirin 325mg po daily versus placebo pill daily intervention 2: Patients randomized to start ART immediately or defer use for 1 month

Protocol document: