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NCT00001357 · ClinicalTrials.gov registry record · Phase 2
Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
A Phase 2 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00001357 is a Phase 2 study of HIV Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001357, a Phase 2 study of HIV Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD. The anticipated accrual will be approximately 15 patients and the study will take one year to complete. Patients will receive Proleukin® (Registered Trademark) subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin® (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone. If tolerated, each patient will receive 3 cycles of therapy and, following completion of three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy.
Conditions Studied
Interventions
- DRUG Interleukin-2
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 1993-08 |
| Est. Completion | 2002-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001357
The ClinicalTrials.gov registry entry for NCT00001357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (67% 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 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Interleukin-2 is the first listed.
NCT00001357 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001357 about?
NCT00001357 is a clinical study titled "Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients". This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD. The anticipated accrual will be approximately 15 patients and the study will take one year to complete...
What is the current status of trial NCT00001357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 1993-08. Estimated completion is 2002-04.
What conditions does trial NCT00001357 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00001357?
The interventions under investigation include: Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT00001357?
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 NCT00001357 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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