Clinical Study

Effect Of Reducing Inflammation With Low Dose Methotrexate On Inflammatory Markers And Endothelial Function In Treated And Suppressed Hiv Infection

Posted Date: Dec 18, 2013

  • Investigator: Carl Fichtenbaum
  • Co-Investigator: Susan Humbert Groh
  • Specialties: AIDS-HIV, Infectious Diseases
  • Type of Study: Drug

We are doing this study to learn more about the effects of low dose methotrexate (LDMTX) on inflammation (irritation) and heart health. LDMTX is a medication used to treat inflammation. It has been used safely in people with joint inflammation for over 20 years in the United States. LDMTX is approved by the United States Food and Drug Administration (FDA) for treating people with rheumatoid arthritis but is not approved for the treatment of HIV infection. Inflammation is the body’s normal reaction to infection. HIV-infected people can have more inflammation in their body even while taking anti-HIV medicines. Also, HIV-infected people who are doing well on anti-HIV medications have a higher chance of getting certain medical problems, including heart disease. If inflammation lasts a long time it may lead to other health problems, such as heart disease or stroke. LDMTX is being used in this study to control inflammation associated with HIV infection. We want to learn if treatment with LDMTX can lower the risk of heart disease by lowering HIV-related inflammation. This will be done by a test that uses an ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD) of the brachial artery. This is a painless test that bounces sound waves off of a blood vessel in your arm. We also want to see how safe LDMTX is when used in people with treated HIV infection.

Criteria:

You Are Being Asked To Take Part In This Research Study Because You Are 40 Years Of Age Or Older And Are: • Infected With Human Immunodeficiency Virus (Hiv), The Virus That Causes Aids, • Have Been Taking Anti-Hiv Medicines For At Least 6 Months, • Your Viral Load Level Is Under Control, • And You Either Have Cardiovascular Disease (Heart Disease) Or You Are At Higher Risk For Cardiovascular Disease (Cvd).

Keywords:

Aids, Hiv, Inflammation, Methotrexate

For More Information:

Tammy Miller
513-584-8373
tammy.miller@uc.edu

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