HIV-1 Infection Clinical Trial
Official title:
A Randomized Controlled Trial to Compare the Effects of Highly Active Antiretroviral Therapy (HAART) Versus Statin Therapy on Endothelial Function and Markers of Inflammation/Coagulation In HIV-Infected Individuals With High CD4 Cell Counts
Since people started taking HIV medications, illnesses related to AIDS have decreased, but
other serious illnesses like heart disease (heart attacks) and certain kinds of cancer have
increased. Studies show that HIV causes changes in the lining of the arteries and also
causes inflammation (irritation) inside the body that may play a role in diseases like heart
attacks and strokes. The levels of inflammation and artery lining health can also affect how
well your brain works. These changes cannot be felt, but can be measured. Artery lining
health can be looked at with a test that uses a blood pressure cuff on your arm to see how
the artery responds when air is let in and out of the cuff. An ultrasound (machine that uses
sound waves) is used to look at the artery during the test. This test is called Flow
Mediated Dilation or FMD for short. Inflammation can be checked with blood tests (blood
tests that measure this irritation inside the body that you cannot feel). HIV medications
can improve the artery lining health and can partially lower levels of inflammation in the
blood; however, these levels of inflammation may not be able to return back to normal.
Pravastatin sodium is a medication that is approved by the Food and Drug Administration
(FDA) for treating high cholesterol. Pravastatin sodium has also been able to improve the
health of the lining of the arteries and lower the level of inflammation in people with
other diseases, but has not been studied or approved for this purpose in people who have
HIV. This research study will look at the effects of two types of medications used
separately or together on the health of the lining of arteries and levels of inflammation in
the blood: Atripla (a HIV medication) and pravastatin sodium. This study will also look at
the effects of Atripla and pravastatin sodium on cholesterol levels, tests that measure how
well you can think and calculate (tests of neurocognitive function), and at the effects of
Atripla on the levels of pravastatin sodium in the blood.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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