Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00000820 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT00000820: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000820 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000820, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Interventions
- DRUG Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Est. Completion | 2002-03 |
| Phase | Phase 2 |
What the finished NCT00000820 record still lists
NCT00000820 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Aldesleukin is the first listed.
NCT00000820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000820 about?
NCT00000820 is a clinical study titled "A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy". PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and ant...
What is the current status of trial NCT00000820?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00000820?
The interventions under investigation include: Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT00000820?
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 NCT00000820's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03403686 · 104 participants
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
- NCT04228367 · 104 participants · NA
JuggerStitch Post Market Clinical Follow-up Study
- NCT04268849 · 104 participants · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- NCT04390724 · 104 participants
Optimizing Y90 Therapy for Radiation Lobectomy