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NCT00001475 · ClinicalTrials.gov registry record · Phase 2
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT00001475 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 85 participants.
The verdict
NCT00001475, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle. To be eligible for home administration of IL-2, patients must: * Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose. * Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions. * Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles. * Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle. * Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff. * Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily. * Have reasonable access to emergency medical services and a nearby medical facility. * Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections. * Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their no
Interventions
- DRUG IL-2 plus Anti-TNF or Thalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 1995-06 |
| Est. Completion | 2002-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001475
The ClinicalTrials.gov registry entry for NCT00001475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 85 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 1 intervention - of which IL-2 plus Anti-TNF or Thalidomide is the first listed.
NCT00001475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001475 about?
NCT00001475 is a clinical study titled "Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist". Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients...
What is the current status of trial NCT00001475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 1995-06. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00001475?
The interventions under investigation include: IL-2 plus Anti-TNF or Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00001475?
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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