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NCT00013611 · ClinicalTrials.gov registry record · Phase 3
Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,695
- Enrollment target
NCT00013611 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 1,695 participants.
The verdict
NCT00013611, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,695 participants
- Enrollment target
Study Summary
This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows HIV disease progression in patients with low CD4+ T cell counts compared with patients taking ART alone. CD4+ T cells are a subset of lymphocytes-white blood cells that are part of the body's immune system. IL-2 is a protein that is naturally produced by lymphocytes. Given in intermittent cycles, IL-2 can raise CD4+ T cell counts in some HIV-infected patients taking antiretroviral drugs. This study will examine whether the increase in CD4+ T cells lowers the risk of AIDS-related illnesses and death. HIV-infected patients 18 years of age and older with a viral load under 10,000 copies per milliliter and a CD4+ T cell count between 50 and 299 cells per cubic millimeter who are taking antiretroviral therapy and who have not previously received IL-2 therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Participation in the study will be from 4.5 to 6 years, depending on what point in the duration of the study the individual patient is enrolled. Patients will be randomly assigned to receive IL-2 plus ART or ART alone. All participants will be advised individually about the best ART regimen for them. Patients in the IL-2 treatment group will be taught how to self-inject IL-2 under the skin (similar to insulin injections). They will inject IL-2 twice a day for 5 days every 8 weeks for the first year (until week 49 of the study). From week 49 on they may receive 5-day cycles of IL-2 every 4 months when needed to maintain CD4+ T cell count elevations. An extra cycle may be given 2 months after the week 49 follow-up visit (see follow-up schedule below), depending on their CD4+ T cell count. Patients whose cell counts have not increased after 12 to 16 months of IL-2 treatment will discuss with the doctor the possibility of stopping IL-2. Those who do stop IL-2 treatment will be asked to remain in t
Interventions
- DRUG Proleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,695 participants |
| Start Date | 2001-03 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00013611
The ClinicalTrials.gov registry entry for NCT00013611 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,695 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proleukin is the first listed.
NCT00013611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00013611 about?
NCT00013611 is a clinical study titled "Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)". This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows HIV disease progression in patients with low CD4+ T cell counts compared with patients taking ART alone. CD4+ T cells are a subset of lymphocytes-white blood cells that are part of the body's immune system. ...
What is the current status of trial NCT00013611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,695 participants. The study started on 2001-03. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00013611?
The interventions under investigation include: Proleukin (DRUG).
Who is sponsoring clinical trial NCT00013611?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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