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Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications

NCT01949116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2021-11-01

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

LDMTX

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

DRUG

Placebo

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

DIETARY_SUPPLEMENT

Folic acid

1-mg tablet of folic acid by mouth once a day

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Priscilla Hsue, MD · San Francisco General Hospital

  • Judith Currier, MD, MSc · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-12-08
Completion
2016-12-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01949116 on ClinicalTrials.gov