At a glance
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Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection
In Brief
A Phase 2 clinical trial evaluating LDMTX, Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 176 participants across 22 sites.
Detailed Summary
People with HIV infection who are taking antiretroviral therapy (ART) could be at risk for cardiovascular disease (CVD), which can be caused by inflammation. Methotrexate (MTX) is a medication used to treat inflammation in people with rheumatoid arthritis. This study evaluated the safety and effectiveness of low-dose methotrexate (LDMTX) at reducing inflammation in HIV-infected adults.
Study Details
Timeline
Interventions
LDMTX 5 mg: one 5-mg capsule by mouth once weekly LDMTX 10 mg: two 5-mg capsules by mouth once weekly LDMTX 15 mg: three 5-mg capsules by mouth once weekly
Placebo 5 mg: one 5-mg capsule by mouth once weekly Placebo 10 mg: two 5-mg capsules by mouth once weekly Placebo 15 mg: three 5-mg capsules by mouth once weekly
1-mg tablet of folic acid by mouth once a day