Trial · NCT00013611
Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)
NCT00013611, Phase 3, Completed, University of Minnesota; results first posted 2010-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study). Trials, record NCT00013611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00013611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)
- NCT number
- NCT00013611
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,695 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- HIV Infection
- Interventions
- Proleukin
- First posted
- 2001-03-26
- Last updated
- 2011-08-08
- Results first posted
- 2010-12-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | New or Recurrent Disease Progression Events, as Defined, or Death. | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause. AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (\> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease. |
| Secondary | All-cause Mortality | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Number of participants who died. |
| Secondary | New or Recurrent Disease Progression Events | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Number of participants with fatal or non-fatal AIDS-related opportunistic disease. AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (\> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease. |
| Secondary | Grade 4 Clinical Events | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention. |
| Secondary | CD4+ Cell Count | Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest . | Mean CD4+ cell count (cells per cubic mm) averaged over follow-up |
| Secondary | New or Recurrent Serious Disease Progression Events or Death | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease. A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | New or Recurrent Disease Progression Events, as Defined, or Death. | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Participants | NUMBER | |
| SECONDARY | All-cause Mortality | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Participants | NUMBER | |
| SECONDARY | New or Recurrent Disease Progression Events | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Participants | NUMBER | |
| SECONDARY | Grade 4 Clinical Events | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | The outcome is the number of participants experiencing at least one grade 4 event. | Participants | NUMBER |
| SECONDARY | CD4+ Cell Count | Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest . | cells per cubic mm | MEAN | |
| SECONDARY | New or Recurrent Serious Disease Progression Events or Death | From randomization to date last known to be alive or November 15, 2008, whichever is earlier | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| New or Recurrent Disease Progression Events, as Defined, or Death. | Proleukin Plus Antiretroviral Therapy | 110 | Participants | ||
| New or Recurrent Disease Progression Events, as Defined, or Death. | Antiretroviral Therapy Only | 119 | Participants | ||
| All-cause Mortality | Proleukin Plus Antiretroviral Therapy | 81 | Participants | ||
| All-cause Mortality | Antiretroviral Therapy Only | 77 | Participants | ||
| New or Recurrent Disease Progression Events | Proleukin Plus Antiretroviral Therapy | 49 | Participants | ||
| New or Recurrent Disease Progression Events | Antiretroviral Therapy Only | 66 | Participants | ||
| Grade 4 Clinical Events | Proleukin Plus Antiretroviral Therapy | 203 | Participants | ||
| Grade 4 Clinical Events | Antiretroviral Therapy Only | 186 | Participants | ||
| CD4+ Cell Count | Proleukin Plus Antiretroviral Therapy | 345.1 | Standard Error 5.1 | cells per cubic mm | |
| CD4+ Cell Count | Antiretroviral Therapy Only | 292.1 | Standard Error 4.1 | cells per cubic mm |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Proleukin Plus Antiretroviral Therapy | 849 | |
| Overall Study | STARTED | Antiretroviral Therapy Only | 846 | |
| Overall Study | COMPLETED | Proleukin Plus Antiretroviral Therapy | 758 | |
| Overall Study | COMPLETED | Antiretroviral Therapy Only | 746 | |
| Overall Study | NOT COMPLETED | Proleukin Plus Antiretroviral Therapy | 91 | |
| Overall Study | NOT COMPLETED | Antiretroviral Therapy Only | 100 |
Source ClinicalTrials.gov
Adverse events248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Aneamias nonhaemolytic and marrow depression | Blood and lymphatic system disorders | Proleukin Plus Antiretroviral Therapy | 3 | 849 | 5 |
| serious | Aneamias nonhaemolytic and marrow depression | Blood and lymphatic system disorders | Antiretroviral Therapy Only | 6 | 846 | 6 |
| serious | Haemolyses and related conditions | Blood and lymphatic system disorders | Proleukin Plus Antiretroviral Therapy | 1 | 849 | 1 |
| serious | Haemolyses and related conditions | Blood and lymphatic system disorders | Antiretroviral Therapy Only | 0 | 846 | 0 |
| serious | Platelet disorders | Blood and lymphatic system disorders | Proleukin Plus Antiretroviral Therapy | 2 | 849 | 2 |
| serious | Platelet disorders | Blood and lymphatic system disorders | Antiretroviral Therapy Only | 0 | 846 | 0 |
| serious | Spleen, lymphatic and reticuloendothelial system disorders | Blood and lymphatic system disorders | Proleukin Plus Antiretroviral Therapy | 1 | 849 | 1 |
| serious | Spleen, lymphatic and reticuloendothelial system disorders | Blood and lymphatic system disorders | Antiretroviral Therapy Only | 0 | 846 | 0 |
| serious | White blood cell disorders | Blood and lymphatic system disorders | Proleukin Plus Antiretroviral Therapy | 0 | 849 | 0 |
| serious | White blood cell disorders | Blood and lymphatic system disorders | Antiretroviral Therapy Only | 1 | 846 | 1 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Proleukin Plus Antiretroviral Therapy | ||
| Total, all-cause mortality | Antiretroviral Therapy Only | ||
| Total, other adverse events | Proleukin Plus Antiretroviral Therapy | 0 | 0 |
| Total, other adverse events | Antiretroviral Therapy Only | 0 | 0 |
| Total, serious adverse events | Proleukin Plus Antiretroviral Therapy | 203 | 849 |
| Total, serious adverse events | Antiretroviral Therapy Only | 186 | 846 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: New or Recurrent Disease Progression Events, as Defined, or Death. | Trial comparisons |
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: All-cause Mortality | Trial comparisons |
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: New or Recurrent Serious Disease Progression Events or Death | Trial comparisons |
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: New or Recurrent Disease Progression Events | Trial comparisons |
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: Grade 4 Clinical Events | Trial comparisons |
| Proleukin Plus Antiretroviral Therapy vs Antiretroviral Therapy Only: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00013611
GET https://conductscience.org/api/trials/v1/NCT00013611/events?page=2