Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
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.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01949116 (Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Adjunct Therapy for CD4Frontiers in immunology · 2021Pooled it
- Rationale, design, and baseline characteristicss of the effect of PCSK9 inhibition on cardiovascular risk in treated HIV infection: EPIC-HIV randomized clinical trial.American heart journal · 2026Trial
- Brief Report: Low-Dose Methotrexate Does Not Affect Measures of HIV-1 Persistence in Individuals With Chronically Treated HIV-1 Infection.Journal of acquired immune deficiency syndromes (1999) · 2024Trial
- The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV.The Journal of infectious diseases · 2021Trial
- Methotrexate Decreases Tenofovir Exposure in Antiretroviral-Suppressed Individuals Living With HIV.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Statin effect on coronary calcium distribution, mass and volume scores and associations with immune activation among HIV+ persons on antiretroviral therapy.Antiviral therapy · 2020Trial
- Brachial Artery Echogenicity and Grayscale Texture Changes in HIV-Infected Individuals Receiving Low-Dose Methotrexate.Arteriosclerosis, thrombosis, and vascular biology · 2018Trial
- The effect of low-dose methotrexate on arterial inflammation in persons living with human immunodeficiency virus: A double-blind randomized placebo-controlled pilot trial.Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2026Article
- Antiviral Drugs in HIV and Cardiovascular Disease: Mechanistic Insights and Clinical Implications.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Understanding residual risk of cardiovascular disease in people with HIV.Current opinion in HIV and AIDS · 2025Review
- Immune Dysregulation in Ischemic Heart Disease Among Individuals with Human Immunodeficiency Virus.Heart failure clinics · 2025Review
- Advances in the Management of Cardiovascular Disease in the Setting of Human Immunodeficiency Virus.Infectious disease clinics of North America · 2024Review
- Inflammatory and Immune Mechanisms for Atherosclerotic Cardiovascular Disease in HIV.International journal of molecular sciences · 2024Review
- Cardiac and Renal Comorbidities in Aging People Living With HIV.Circulation research · 2024Review
- Inflammation in HIV and Its Impact on Atherosclerotic Cardiovascular Disease.Circulation research · 2024Review
- Evolving mechanisms and presentations of cardiovascular disease in people with HIV: implications for management.Clinical microbiology reviews · 2024Review
- Moderate to Intense Physical Activity Is Associated With Improved Clinical, CD4/CD8 Ratio, and Immune Activation Status in HIV-Infected Patients on ART.Open forum infectious diseases · 2022Article
- Methotrexate Inhibits T Cell Proliferation but Not Inflammatory Cytokine Expression to Modulate Immunity in People Living With HIV.Frontiers in immunology · 2022Article
- Effect of HIV-1 Infection on Angiopoietin 1 and 2 Levels and Measures of Microvascular and Macrovascular Endothelial Dysfunction.Journal of the American Heart Association · 2021Observational
- The Adenosine Pathway and Human Immunodeficiency Virus-Associated Inflammation.Open forum infectious diseases · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundChronic inflammation in treated HIV infection is associated with mortality and atherosclerotic cardiovascular disease (ASCVD). We evaluated the safety and potential efficacy of low-dose methotrexate (LDMTX) in treated HIV.
methodsThis was a phase 2 randomized, double-blind, multicenter trial in adults ≥40 years old with treated HIV, with CD4+ T-cell count ≥400 cells/μL and with/at increased risk for ASCVD. Participants received LDMTX (5-15 mg/week) or placebo (plus folic acid) for 24 weeks and were followed for an additional 12 weeks. Primary endpoints were safety and brachial artery flow-mediated dilation (FMD).
resultsThe 176 participants (90% male) had a median (Q1, Q3) age of 54 (49, 59) years. LDMTX was associated with decreases in CD4+ T cells at week 24 and CD8+ T cells at weeks 8, 12, and 24. Eleven participants (12.8%) experienced safety events in the LDMTX group vs 5 (5.6%) in placebo (Δ = 7.2%, upper 1-sided 90% CI, 13.4%; Pnoninferiority = .037). Week 24 change in FMD was 0.47% with LDMTX and 0.09% with placebo (P = .55). No inflammatory markers changed differentially with LDMTX compared to placebo.
conclusionsAdults with HIV and increased ASCVD risk treated with LDMTX had more safety events than with placebo, but the prespecified noninferiority margin of 15% was not exceeded. LDMTX had no significant effect on endothelial function or inflammatory biomarkers but was associated with a significant decrease in CD8+ T cells. The balance of risks and potential benefits of LDMTX in this population will require additional investigation. CLINICAL TRIALS REGISTRATION: NCT01949116.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.