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Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation

NCT01515813 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-02-01

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Pravastatin sodium

One 40 mg tablet of Pravastatin sodium taken orally once daily.

DRUG

Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate

Participant will be administered one tablet of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)600 mg/200 mg/300 mg taken orally once daily

DRUG

Pravastatin sodium

Two 40mg tablets (80 mg total) of Pravastatin sodium taken orally once daily.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • David A. Wohl, M.D. · University of North Carolina AIDS CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515813 on ClinicalTrials.gov