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NCT02312219 · ClinicalTrials.gov registry record
PET/CT Imaging Companion Study To ACTG A5314
A clinical trial of HIV and Inflammation, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 35
- Enrollment target
- 1
- Study location
NCT02312219 is a study of HIV and Inflammation that has completed, run by Massachusetts General Hospital. The registered enrollment target is 35 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02312219, a study of HIV and Inflammation, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
HIV-infected individuals on antiretroviral therapy (ART) are at increased risk for cardiovascular disease (CVD), likely due to chronically increased inflammation. Low-dose methotrexate (LDMTX) may reduce CVD risk in people with rheumatoid arthritis, who like those with HIV, have increased levels of inflammation. The NHLBI is funding a clinical trial targeting the excess inflammation in HIV. That "Parent Study" is a randomized, double-blind, placebo-controlled trial (NCT01949116) that will assess whether 24-week treatment with LDMTX: i) is safe, ii) reduces circulating inflammatory biomarkers and levels of immune cell activation and iii) improves brachial artery reactivity. However, neither the biomarkers nor endothelial function tests measured as part of the parent study will report on atherosclerotic inflammation, (the desired pathobiological target of LDMTX therapy in HIV). As such, the direct evaluation of arterial inflammation would substantially enhance the scientific value of the trial. In this imaging sub-study, the overall goal is to determine if treating virologically suppressed, HIV-infected individuals with LDMTX will reduce inflammation within the arterial wall. This fully integrated ancillary study would, in a subset of patients enrolled in the parent trial: (i) assess the impact of LDMTX on arterial inflammation, (ii) evaluate mechanisms responsible for arterial inflammation in HIV and iii) explore mechanisms responsible for actions of LDMTX on the artery wall. Accordingly, the proposed study would provide unique and highly complementary information that would greatly increase the knowledge and mechanistic insights gained from Parent Study. The ancillary study has two specific aims1) To determine the impact of anti-inflammatory treatment with LDMTX on arterial inflammation, as assessed by FDG-PET/CT imaging, in virally suppressed HIV-infected individuals., and 2) To evaluate the cellular and biochemical basis of the effect of LDMTX therapy on arterial
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Folic Acid
- DRUG Low Dose Methotrexate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-12-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02312219
The ClinicalTrials.gov registry entry for NCT02312219 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02312219 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02312219 about?
NCT02312219 is a clinical study titled "PET/CT Imaging Companion Study To ACTG A5314". HIV-infected individuals on antiretroviral therapy (ART) are at increased risk for cardiovascular disease (CVD), likely due to chronically increased inflammation. Low-dose methotrexate (LDMTX) may reduce CVD risk in people with rheumatoid arthritis, who like those with HIV, have increased levels of ...
What is the current status of trial NCT02312219?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2014-11. Estimated completion is 2016-12-08.
What conditions does trial NCT02312219 study?
This clinical trial studies the following conditions: HIV, Inflammation, Atherosclerosis.
What interventions are being tested in trial NCT02312219?
The interventions under investigation include: Placebo (DRUG), Folic Acid (DRUG), Low Dose Methotrexate (DRUG).
Who is sponsoring clinical trial NCT02312219?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02312219 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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