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HIV InfectionsPhase 2NCT01949116

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

A Phase 2 study testing LDMTX and Folic acid in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
HIV Infections
What is being tested?
LDMTX and Folic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
22 sitesUnited States
Study dates
31 Jan 2014to 8 Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
  • Had to be on continuous ART for greater than or equal to 24 weeks prior to study entry. This was defined as continuous active therapy for the 24-week period prior to study entry with no treatment interruption longer than 7 consecutive days and a total duration off treatment of no more than 14 days in the 90 days prior to study entry.
  • CD4 T-cell count greater than or equal to 400 cells/mm^3 obtained within 60 days prior to study entry by any U.S. laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent
  • HIV-1 RNA level below the limit of quantification using a FDA-approved assay for at least 24 weeks prior to study entry and confirmed within 60 days prior to study entry. The assay used for eligibility could be performed by any U.S. laboratory that had a CLIA certification or its equivalent. NOTE: Single determinations that are between the assay quantification limit and 200 copies/mL were allowed as long as the preceding and subsequent determinations are below the level of quantification.
  • The following laboratory values obtained within 60 days prior to study entry by any U.S. laboratory that has a CLIA certification or its equivalent:
  • Fasting glucose less than 180 mg/dL
Show all 33Show fewer
  • Alanine aminotransferase (ALT) [serum glutamic pyruvic transaminase (SGPT)] less than 2 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase (SGOT)] less than 2 times the ULN
  • Estimated creatinine clearance (CrCl) greater than or equal to 50 mL/min by Cockcroft-Gault. NOTE: Candidates who were taking tenofovir disoproxil fumarate (TDF) as part of their ART regimen should have an estimated CrCl greater than or equal to 60 mL/min.
  • White blood cell (WBC) greater than 3,000/mm^3
  • Hemoglobin greater than 12.0 g/dL
  • Platelets greater than 150,000/mm^3
  • Female candidates who were postmenopausal (i.e., of non-childbearing potential) were defined as having either:
  • Appropriate medical documentation of prior hysterectomy and/or complete bilateral oophorectomy (i.e., surgical removal of the ovaries, resulting in "surgical menopause" and occurring at the age at which the procedure was performed), OR
  • Permanent cessation of previously occurring menses as a result of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., "spontaneous menopause").
  • Male candidates must agree not to participate in a conception process (i.e., active attempt to impregnate, sperm donation). If participating in sexual activity that could lead to pregnancy, the male participant must agree to the use of TWO reliable forms of contraceptives simultaneously while on study and for a minimum of 3 months after therapy.
  • Candidates who were not of reproductive potential (defined as women who have been postmenopausal for at least 24 consecutive months or men who have documented vasectomy) were eligible for the study without requiring the use of contraceptives.
  • Moderate or high CVD risk defined as:
  • Documented CVD as assessed by meeting at least 1 of 3 criteria below:
  • Coronary artery disease (CAD): prior myocardial infarction (MI) due to atherosclerosis, coronary artery bypass graft surgery, percutaneous coronary intervention, or angiographic CAD with luminal diameter stenosis of at least one coronary artery at least 50%.
  • Cerebrovascular disease: prior ischemic stroke of carotid origin, carotid endarterectomy or stenting, or angiographic carotid stenosis of at least 50%.
  • Peripheral arterial disease: prior lower extremity arterial surgical or percutaneous revascularization procedure, or angiographic lower extremity arterial stenosis of at least 50%.
  • OR
  • Controlled type II diabetes mellitus (HbA1C less than or equal to 8.0% within the past 90 days prior to study entry, regardless of use of medications)
  • OR
  • Any one of the following CVD risk factors below:
  • Current smoking: self-report of smoking at least a half a pack of cigarettes a day, on average, in the past month.
  • Hypertension (HTN): two consecutive blood pressure (BP) readings with either systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg; or on antihypertensive medications.
  • Dyslipidemia: defined as non-high-density lipoprotein (HDL)-C greater than 160 mg/dL or HDL-C less than or equal to 40 mg/dL, regardless of medication use.
  • High-sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L at screening
  • Ability and willingness of candidate to provide informed consent
  • Completion of the Flow-mediated Vasodilation (FMD) assessments. NOTE: The FMD must be performed at the site and confirmed as acceptable by the University of Wisconsin Atherosclerosis Imaging Research Program (UW AIRP) core lab prior to study entry. If the FMD is deemed unacceptable, a repeat scan must be performed prior to enrollment.
  • Appropriate documentation from medical records of prior receipt of pneumococcal vaccination (with both the 13-valent conjugant vaccine [PCV13] and 23-valent pneumococcal polysaccharide vaccine [PPV23]) within the last 5 years. If no documentation is available, then the PCV13 and PPV23 series (PCV13 vaccine followed by PPV23 vaccine at least 8 weeks later) should be completed more than 14 days prior to study entry.

Who cannot join

  • Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry. NOTE: Treatment should have ended at least 60 days prior to study entry for eligibility.
  • Documentation of any CDC category C AIDS-indicator condition or oropharyngeal candidiasis (thrush) within 90 days prior to study entry
  • Receipt of antibiotic therapy within 30 days prior to study entry
  • Latent tuberculosis (TB) infection (defined as a positive purified protein derivative [PPD] greater than or equal to 5 mm, positive interferon-gamma release assay, or positive T-spot test at any time in the past) or evidence of latent TB on the screening chest x-ray that had not been completely treated or was treated within the past 6 months prior to study entry
  • TB disease that required treatment within 48 weeks prior to study entry
  • Life-threatening fungal infection requiring treatment, in the opinion of the site investigator, within 48 weeks prior to study entry
Show all 24Show fewer
  • Herpes-zoster viral infection that required treatment within 90 days prior to study entry
  • A history of or current, active hepatitis B infection defined as positive hepatitis B surface antigen (HBsAg) test or positive hepatitis B virus (HBV) DNA in candidates with isolated hepatitis B core antibody (HBcAb) positivity, defined as negative HBsAg, negative hepatitis B surface antibody (HBsAb), and positive HBcAb within 24 weeks prior to study entry. NOTE: Candidates who were positive for hepatitis B surface antigen but who were HBV DNA negative were permitted in the study.
  • Chronic hepatitis C infection defined as a positive hepatitis C antibody and positive hepatitis C RNA at any time prior to study entry. NOTE: Candidates who were positive for hepatitis C antibody but whowerehepatitis C virus (HCV) RNA negative are permitted in the study. Candidates who had been treated for hepatitis C should be HCV RNA negative for at least 24 weeks after completion of therapy to be eligible for the study.
  • Previously diagnosed myelodysplasia syndrome
  • Treated lymphoproliferative disease less than or equal to 5 years prior to study entry
  • Clinically significant lung disease on the screening chest x-ray that, in the opinion of the site investigator, places the candidate at increased risk of lung toxicity (e.g., history of pulmonary fibrosis, interstitial lung disease, or pulmonary lymphoproliferative disease)
  • Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry
  • Change in the ART regimen in the 12 weeks prior to study entry or intended modification of ART during the study. NOTE: Modifications of ART doses during the 12 weeks prior to study entry were permitted. In addition, the change in formulation (e.g., from standard formulation to fixed-dose combination) was allowed within 12 weeks prior to study entry. A within class single drug substitution (e.g., switch from nevirapine to efavirenz or from atazanavir to darunavir) is allowed within 12 weeks prior to study entry, with the exception of a switch from any other nucleoside reverse transcriptase inhibitor (NRTI) to abacavir. No other changes in ART in the 12 weeks prior to study entry were permitted.
  • Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
  • Average daily consumption of three or more alcoholic beverages for 4 weeks prior to study entry or intention to consume an average of two or more alcoholic beverages a day during the study. NOTE: An alcohol-containing beverage is defined as 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Changes in lipid-lowering or antihypertensive medication within 90 days prior to study entry or expected need to modify these medications during the study. NOTE: Lipid-lowering medication includes: statins, fibrates, niacin (dose greater than or equal to 250 mg daily), and fish-oil/omega 3 fatty acids (dose greater than 1000 mg of marine oils daily).
  • Vaccination (e.g., influenza, pneumococcal polysaccharide) within 14 days prior to study entry
  • Anticipated need to receive vaccination (e.g., influenza, pneumococcal polysaccharide) within 1 week prior to Week 4, 12, 24, or 36 study visits
  • Excess extracompartmental fluids including ascites, pericardial fluid, and pleural effusions which, in the opinion of the study investigators, would result in difficulty in monitoring the dose of MTX
  • Use of drugs that alter folic acid metabolism such as trimethoprim/sulfamethoxazole or reduce tubular excretion such as probenecid within 14 days prior to study entry
  • New York Heart Association Class IV congestive heart failure
  • Diabetes mellitus with HbA1C greater than 8.0% within the past 90 days prior to study entry

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Alabama CRS

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS

    Boston, Massachusetts, 02115

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cincinnati Clinical Research Site

    Cincinnati, Ohio, 45219

  • Case Clinical Research Site

    Cleveland, Ohio, 44106

  • Ohio State University CRS

    Columbus, Ohio, 43210

  • Greensboro CRS

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • University of Southern California CRS

    Los Angeles, California, 90033-1079

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • Penn Therapeutics, CRS

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hospital Clinical Research Site (TMH CRS) CRS

    Providence, Rhode Island, 02906

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • Ucsf Hiv/Aids Crs

    San Francisco, California, 94110

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Harbor-UCLA CRS

    Torrance, California, 90502

Other trials in United States

About this study

Official title: Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection

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.

Read the detailed description

HIV-infected people taking ART have a higher than expected risk of premature CVD. Many factors likely contribute to this risk, including chronic inflammation. Strategies to reduce inflammation in HIV-infected people may be beneficial in reducing CVD risk, as well as other conditions, including kidney disease, bone disease, and neurologic complications. MTX is an anti-inflammatory medication used to treat people with rheumatoid arthritis. This study evaluated the safety and effectiveness of LDMTX at treating inflammation and on endothelial function in virologically suppressed HIV-infected adults who had CVD or were at increased risk of CVD.

The total study duration was 36 weeks. Prior to enrolling in the study, participants had a chest X-ray. Participants were randomly assigned to receive LDMTX or placebo for 24 weeks. Participants continued taking their antiretroviral (ARV) medications as usual; ARVs were not provided by the study. At study entry, participants underwent a medical and medication history, physical examination, blood collection, and adherence assessments. From study entry through Week 1, participants received either 5 mg of LDMTX or placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX or placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX or placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to LDMTX or placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX or placebo, all participants continued taking folic acid for an additional 4 weeks.

Post-entry visits occurred at Weeks 1, 2, 4, 8, 12, 18, 24, and 36. These included a physical examination, blood collection, and adherence assessments; an arm ultrasound test was performed at Weeks 12 and 24. At Week 2, some participants took part in a pharmacokinetic (PK) assessment, which involved undergoing a blood collection several times over a 6-hour period.

Conditions
HIV Infections
Being tested
LDMTX, Placebo, Folic acid
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDMTXDrug

    Also called Low-Dose Methotrexate

    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

  • PlaceboDrug

    Also called Placebo for Low-Dose Methotrexate

    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

  • Folic acidDietary supplement

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

Study groups in NCT01949116
Study groupRoleWhat they receive
Low-dose methotrexate (LDMTX)ExperimentalFrom study entry through Week 1, participants received 5 mg of LDMTX once a week. For participants who were clinically stable at the Week 1 study visit, the dose of LDMTX was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of LDMTX was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to LDMTX, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of LDMTX, all participants continued taking folic acid for an additional 4 weeks.
Receives: Drug: LDMTX; Dietary Supplement: Folic acid
PlaceboPlacebo comparatorFrom study entry through Week 1, participants received 5 mg of placebo once a week. For participants who were clinically stable at the Week 1 study visit, the dose of placebo was increased to 10 mg once a week through Week 12. For participants who were clinically stable at the Week 12 study visit, the dose of placebo was increased to 15 mg once a week through Week 24. Participants who did not meet the criteria for dose escalation were re-evaluated at the following study visit. In addition to placebo, all participants also received 1 mg of folic acid once a day from study entry throughout Week 24. After taking the final dose of placebo, all participants continued taking folic acid for an additional 4 weeks.
Receives: Drug: Placebo; Dietary Supplement: Folic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks)

    Number of participants who experienced any one of the following safety milestones:

    • Entry CD4+ T-cell count less than 700 cells/mm^3, confirmed CD4+ decline greater than 33% of baseline AND to less than 350 cells/mm^3
    • Entry CD4+ T-cell count greater than or equal to 700 cells/mm^3, a confirmed CD4+ decline greater than 50% of baseline
    • Confirmed HIV-1 RNA Level Greater Than 200 Copies/mL in the Absence of an Interruption in ART
    • New or recurrent CDC category C AIDS-indicator condition
    • Evidence of HIV-associated infection including CMV end-organ disease, varicella zoster, EBV related clinical disease
    • Requirement for LDMTX discontinuation for confirmed Grade 3 or higher toxicity
    • Lymphoproliferative malignancies
    • Pulmonary toxicity which is defined as Grade 3 or 4 dyspnea, cough, shortness of breath which in the opinion of the local investigator is related to the study drug but not related to other clinical causes such as asthma, influenza, etc.

    Measured: From study entry to week 36

  2. Primary Efficacy Endpoint of Change From Baseline to Week 24 in Brachial Artery Flow-mediated Vasodilation (FMD)

    Flow-mediated vasodilation is defined as the maximum FMD (%) calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter. Absolute change of FMD at week 24 is calculated from baseline FMD.

    Measured: From Baseline to Week 24

Secondary outcomes (12)

  1. Change From Baseline to Week 12 in Brachial Artery FMD

    The absolute change from baseline to week 24 FMD (%), defined as the maximum FMD calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter.

    Measured: From Baseline to Week 12

  2. Change From Baseline to Week 12 in Brachial Artery Resting Average Diameter

    The change in resting average diameter in millimeters of the brachial artery at week 12 from baseline.

    Measured: From Baseline to Week 12

  3. Change From Baseline to Week 24 in Brachial Artery Resting Average Diameter

    The absolute change in resting average diameter in millimeters of the brachial artery at week 24 from baseline.

    Measured: From Baseline to Week 24

  4. Change From Baseline to Week 24 in Reactive Hyperemic (RH) Flow Rate

    The absolute change in RH flow rate in cc/min of the brachial artery at week 24 from baseline.

    Measured: From Baseline to Week 24

  5. Change From Baseline to Week 24 in Peak Reactive Hyperemic (RH) Flow Velocity

    The absolute change in peak RH flow velocity in cm/s of the brachial artery at week 24 from baseline.

    Measured: From Baseline to Week 24

  6. Percentage Change From Baseline to Week 24 in High-sensitivity C-reactive Protein (hsCRP)

    hsCRP is a marker of inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. One single hsCRP result at week 24 was above the limit of quantification, therefore excluded from analysis.

    Measured: From Baseline to week 24

  7. Percentage Change From Baseline to Week 24 in Interleukin-6 (IL-6)

    IL-6 is a marker of systemic inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.

    Measured: From Baseline to Week 24

  8. Percentage Change From Baseline to Week 24 in Soluble CD 163 (sCD163)

    sCD163 is a marker of Macrophage activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.

    Measured: From Baseline to Week 24

  9. Percentage Change From Baseline to Week 24 in D-Dimer

    D-dimer (or D dimer) is a marker of coagulation activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.

    Measured: From Baseline to Week 24

  10. Absolute Change From Baseline to Week 24 in Monocyte Levels

    Three categories of monocyte levels are presented: classical (CD14+CD16-), intermediate (CD14+CD16+), and non-classical (CD14dimCD16+). Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells that express the subset of interest.

    Measured: From Baseline to Week 24

  11. Absolute Change From Baseline to Week 24 in Adhesion and Activation Indices

    The adhesion and activation indices of interest are the percentages of CD38+HLADR+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CD38+HLADR+ cells.

    Measured: From Baseline to Week 24

  12. Absolute Change From Baseline to Week 24 in Homing Molecule (CX3CR1+) Expression

    CX3CR1+ is a cellular marker of immune activation. The outcome measured is the percentages of CX3CR1+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CX3CR1+ cells.

    Measured: From Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study start31 Jan 2014
  3. Primary completion8 Dec 2016
  4. Study completion8 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949116
Sponsor's protocol ID
A5314
Other IDs
11875
Status last verified
Oct 2021
First submitted
19 Sep 2013
Last updated
1 Nov 2021
Data monitoring committee
Yes

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.

    PubMed 39287554

  • 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.

    PubMed 30219823

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDMTX and Folic acid in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks) (time frame: From study entry to week 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949116, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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