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NCT01949116 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
NCT01949116: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01949116 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 176 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01949116, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
Study 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.
Primary Outcome
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 *
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Folic acid
- DRUG LDMTX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2014-01-31 |
| Est. Completion | 2016-12-08 |
| Phase | Phase 2 |
What the finished NCT01949116 record still lists
NCT01949116 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01949116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01949116 about?
NCT01949116 is a clinical study titled "Safety and Effectiveness of Low-Dose Methotrexate for Reducing Inflammation in HIV-Infected Adults on ARV Medications". 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 effecti...
What is the current status of trial NCT01949116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2014-01-31. Estimated completion is 2016-12-08.
What interventions are being tested in trial NCT01949116?
The interventions under investigation include: Placebo (DRUG), Folic acid (DIETARY_SUPPLEMENT), LDMTX (DRUG).
Who is sponsoring clinical trial NCT01949116?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01949116's enrollment target sits among peer trials
176 394th of 2000 higher than 1,605 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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