Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation
Status:
Withdrawn
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Pravastatin Tenofovir