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NCT00004978 · ClinicalTrials.gov registry record · Phase 3
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 4,150
- Enrollment target
NCT00004978: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00004978 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 4,150 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (438% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004978, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,150 participants
- Enrollment target
Study Summary
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
Primary Outcome
Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease
Interventions
- DRUG Recombinant interleukin-2 (rIL-2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,150 participants |
| Start Date | 2000-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00004978 record still lists
NCT00004978 is an interventional study that assigns participants to a tested intervention. Its 4,150 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (438% higher).
The record links to 0 conditions, and to 1 intervention - of which Recombinant interleukin-2 (rIL-2) is the first listed.
NCT00004978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004978 about?
NCT00004978 is a clinical study titled "An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy". The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has ...
What is the current status of trial NCT00004978?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,150 participants. The study started on 2000-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00004978?
The interventions under investigation include: Recombinant interleukin-2 (rIL-2) (DRUG).
Who is sponsoring clinical trial NCT00004978?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004978's enrollment target sits among peer trials
4,150 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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