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NCT00000834 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Methotrexate for HIV Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00000834 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.
The verdict
NCT00000834, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.
Interventions
- DRUG Zidovudine
- DRUG Methotrexate
- DRUG Lamivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Est. Completion | 2002-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000834
The ClinicalTrials.gov registry entry for NCT00000834 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT00000834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000834 about?
NCT00000834 is a clinical study titled "A Phase I Study of Methotrexate for HIV Infection". To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of...
What is the current status of trial NCT00000834?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00000834?
The interventions under investigation include: Zidovudine (DRUG), Methotrexate (DRUG), Lamivudine (DRUG).
Who is sponsoring clinical trial NCT00000834?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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