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Trial · NCT02312219

PET/CT Imaging Companion Study To ACTG A5314

NCT02312219, Completed, Massachusetts General Hospital; results first posted 2019-02-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. PET/CT Imaging Companion Study To ACTG A5314. Trials, record NCT02312219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02312219

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
PET/CT Imaging Companion Study To ACTG A5314
NCT number
NCT02312219
Status
Completed
Enrollment
35 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
HIV, Inflammation, Atherosclerosis
Interventions
Folic Acid, Placebo, Low Dose Methotrexate
First posted
2014-12-09
Last updated
2019-02-06
Results first posted
2019-02-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Arterial FDG Uptake (From Baseline) in the Most Diseased Segmentbaseline and 24 weeks
Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time. The most diseased segment is the approx 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the median value, of the TBR, from baseline to week 24
SecondaryChange in Arterial FDG Uptake (From Baseline) in the Aortabaseline and 24 weeks
Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time. The entire ascending aorta is used for this analysis. The results are expressed as the change in the median value, of the TBR, from baseline to week 24

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Arterial FDG Uptake (From Baseline) in the Most Diseased Segmentbaseline and 24 weeksTBRMEDIAN
SECONDARYChange in Arterial FDG Uptake (From Baseline) in the Aortabaseline and 24 weeksTBRMEDIAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Arterial FDG Uptake (From Baseline) in the Most Diseased SegmentLow Dose Methotrexate-0.126Inter-Quartile Range -0.41 to 0.258TBR
Change in Arterial FDG Uptake (From Baseline) in the Most Diseased SegmentPlacebo0.026Inter-Quartile Range -0.176 to 0.438TBR
Change in Arterial FDG Uptake (From Baseline) in the AortaLow Dose Methotrexate-0.064Inter-Quartile Range -0.327 to 0.113TBR
Change in Arterial FDG Uptake (From Baseline) in the AortaPlacebo0.063Inter-Quartile Range -0.13 to 0.425TBR

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDLow Dose Methotrexate13
Overall StudySTARTEDPlacebo22
Overall StudyCOMPLETEDLow Dose Methotrexate12
Overall StudyCOMPLETEDPlacebo16
Overall StudyNOT COMPLETEDLow Dose Methotrexate1
Overall StudyNOT COMPLETEDPlacebo6

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityLow Dose Methotrexate
Total, all-cause mortalityPlacebo
Total, other adverse eventsLow Dose Methotrexate012
Total, other adverse eventsPlacebo016
Total, serious adverse eventsLow Dose Methotrexate012
Total, serious adverse eventsPlacebo016

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Low Dose Methotrexate vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02312219

GET https://conductscience.org/api/trials/v1/NCT02312219/registered