drugset / Trial / NCT01949116
Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-01-31
- Primary completion
- 2016-12-08
- Completion
- 2016-12-08
Publications
- Cyktor JC, Yeh E, Ribaudo H, Hoeth D, Naqvi A, Bell T, Ridker PM, Fichtenbaum C, Daar ES, Havlir D, Tawakol A, Lederman MM, Stein JH, Deeks SG, Currier JS, Hsue PY, Mellors JW; A5314 Team. Brief Report: Low-Dose Methotrexate Does Not Affect Measures of HIV-1 Persistence in Individuals With Chronically Treated HIV-1 Infection. J Acquir Immune Defic Syndr. 2024 Aug 15;96(5):481-485. doi: 10.1097/QAI.0000000000003453.
- Hsue PY, Ribaudo HJ, Deeks SG, Bell T, Ridker PM, Fichtenbaum C, Daar ES, Havlir D, Yeh E, Tawakol A, Lederman M, Currier JS, Stein JH. Safety and Impact of Low-dose Methotrexate on Endothelial Function and Inflammation in Individuals With Treated Human Immunodeficiency Virus: AIDS Clinical Trials Group Study A5314. Clin Infect Dis. 2019 May 17;68(11):1877-1886. doi: 10.1093/cid/ciy781.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 15 mg | Oral |