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NCT00001048 · ClinicalTrials.gov registry record · Phase 2
Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
A Phase 2 study of HIV Infections and Leukoencephalopathy, Progressive Multifocal, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 9
- Study locations
NCT00001048 is a Phase 2 study of HIV Infections and Leukoencephalopathy, Progressive Multifocal that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 90 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The trial reports 9 study locations across 9 states.
The verdict
NCT00001048, a Phase 2 study of HIV Infections and Leukoencephalopathy, Progressive Multifocal, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 9
- Study locations
Study Summary
To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies. The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Zidovudine
- DRUG Filgrastim
- DRUG Didanosine
- DRUG Zalcitabine
Study Locations (9)
Colorado
- University of Colorado Hospital CRS - Aurora
Florida
- Univ. of Miami AIDS CRS - Miami
Illinois
- Northwestern University CRS - Chicago
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
Massachusetts
- Massachusetts General Hospital ACTG CRS - Boston
Missouri
- Washington U CRS - St Louis
New York
- Univ. of Rochester ACTG CRS - Rochester
North Carolina
- Unc Aids Crs - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Est. Completion | 1997-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001048
The ClinicalTrials.gov registry entry for NCT00001048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). 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 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cytarabine is the first listed.
NCT00001048 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Colorado, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00001048 about?
NCT00001048 is a clinical study titled "Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients". To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6...
What is the current status of trial NCT00001048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. Estimated completion is 1997-04.
What conditions does trial NCT00001048 study?
This clinical trial studies the following conditions: HIV Infections, Leukoencephalopathy, Progressive Multifocal.
What interventions are being tested in trial NCT00001048?
The interventions under investigation include: Cytarabine (DRUG), Zidovudine (DRUG), Filgrastim (DRUG), Didanosine (DRUG), Zalcitabine (DRUG).
Who is sponsoring clinical trial NCT00001048?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001048 being conducted?
This trial has 9 study locations across Colorado, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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