Trial · NCT00004978
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
NCT00004978, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2011-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy. Trials, record NCT00004978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
- NCT number
- NCT00004978
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,150 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Recombinant interleukin-2 (rIL-2)
- First posted
- 2001-08-31
- Last updated
- 2021-11-05
- Results first posted
- 2011-04-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | New or Recurrent HIV Disease Progression Event Including Death | from randomization through study end - median of 7.6 years follow-up | 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 |
| Secondary | New or Recurrent Serious HIV Disease Progression Event Including Death | from randomization through study end - median of 7.6 years follow-up | Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease. |
| Secondary | Number of Participants Who Died From Any Cause | from randomization through study end - median of 7.6 years follow-up | |
| Secondary | Participants With a New Disease Progression Event or Death | from randomization through 15 November 2008 - median of 7.6 years follow-up | Includes first new episode of: CDC Category C 1993 AIDS-defining events plus 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 |
| Secondary | Absolute CD4 Cell Counts Averaged Throughout Followup | from randomization through study end - median of 7.6 years follow-up | Average of all available CD4+ cell counts measured at follow-up visits |
| Secondary | Plasma HIV RNA Levels | From randomization through study end - median of 7.6 years follow-up | log10 HIV-RNA averaged throughout follow-up |
| Secondary | Number of Participants With Changes in Anti-retroviral Treatment (ART) | From randomization through study end - median of 7.6 years follow-up | Number of participants who changed ART at least once during the study period. |
| Secondary | Grade 4 Signs and Symptoms | From randomization through study end - median of 7.6 years follow-up | Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section. |
| Secondary | Pattern of Use of Prophylaxis for Opportunistic Infections | last followup visit - median of 7.6 years follow-up | Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit. |
| Secondary | Hepatic, Metabolic, and Cardiac Conditions | From randomization through study end - median of 7.6 years follow-up | Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | New or Recurrent HIV Disease Progression Event Including Death | from randomization through study end - median of 7.6 years follow-up | ITT | participants | NUMBER |
| SECONDARY | New or Recurrent Serious HIV Disease Progression Event Including Death | from randomization through study end - median of 7.6 years follow-up | ITT | participants | NUMBER |
| SECONDARY | Number of Participants Who Died From Any Cause | from randomization through study end - median of 7.6 years follow-up | participants | NUMBER | |
| SECONDARY | Participants With a New Disease Progression Event or Death | from randomization through 15 November 2008 - median of 7.6 years follow-up | participants | NUMBER | |
| SECONDARY | Absolute CD4 Cell Counts Averaged Throughout Followup | from randomization through study end - median of 7.6 years follow-up | CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up. | cells/mm^3 | MEAN |
| SECONDARY | Plasma HIV RNA Levels | From randomization through study end - median of 7.6 years follow-up | HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement. | log10 HIV-RNA | MEAN |
| SECONDARY | Number of Participants With Changes in Anti-retroviral Treatment (ART) | From randomization through study end - median of 7.6 years follow-up | participants | NUMBER | |
| SECONDARY | Grade 4 Signs and Symptoms | From randomization through study end - median of 7.6 years follow-up | Participants | NUMBER | |
| SECONDARY | Pattern of Use of Prophylaxis for Opportunistic Infections | last followup visit - median of 7.6 years follow-up | Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit. | participants | NUMBER |
| SECONDARY | Hepatic, Metabolic, and Cardiac Conditions | From randomization through study end - median of 7.6 years follow-up | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| New or Recurrent HIV Disease Progression Event Including Death | rIL-2 | 159 | participants | ||
| New or Recurrent HIV Disease Progression Event Including Death | No rIL-2 | 165 | participants | ||
| New or Recurrent Serious HIV Disease Progression Event Including Death | rIL-2 | 126 | participants | ||
| New or Recurrent Serious HIV Disease Progression Event Including Death | No rIL-2 | 130 | participants | ||
| Number of Participants Who Died From Any Cause | rIL-2 | 107 | participants | ||
| Number of Participants Who Died From Any Cause | No rIL-2 | 116 | participants | ||
| Participants With a New Disease Progression Event or Death | rIL-2 | 154 | participants | ||
| Participants With a New Disease Progression Event or Death | No rIL-2 | 164 | participants | ||
| Absolute CD4 Cell Counts Averaged Throughout Followup | rIL-2 | 715.4 | Standard Deviation 273.1 | cells/mm^3 | |
| Absolute CD4 Cell Counts Averaged Throughout Followup | No rIL-2 | 556.3 | Standard Deviation 193.0 | cells/mm^3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rIL-2 | 2,090 | |
| Overall Study | STARTED | No rIL-2 | 2,060 | |
| Overall Study | COMPLETED | rIL-2 | 1,846 | |
| Overall Study | COMPLETED | No rIL-2 | 1,790 | |
| Overall Study | NOT COMPLETED | rIL-2 | 244 | |
| Overall Study | NOT COMPLETED | No rIL-2 | 270 |
Source ClinicalTrials.gov
Adverse events342
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 |
|---|---|---|---|---|---|---|
| other | Acute myocardial infarction | Cardiac disorders | rIL-2 | 16 | 2,071 | |
| other | Acute myocardial infarction | Cardiac disorders | No rIL-2 | 15 | 2,040 | |
| other | Anaemia | Blood and lymphatic system disorders | rIL-2 | 9 | 2,071 | |
| other | Anaemia | Blood and lymphatic system disorders | No rIL-2 | 10 | 2,040 | |
| other | Appendicitis | Infections and infestations | rIL-2 | 10 | 2,071 | |
| other | Appendicitis | Infections and infestations | No rIL-2 | 8 | 2,040 | |
| other | Cerebrovascular accident | Nervous system disorders | rIL-2 | 12 | 2,071 | |
| other | Cerebrovascular accident | Nervous system disorders | No rIL-2 | 4 | 2,040 | |
| other | Coronary artery disease | Cardiac disorders | rIL-2 | 12 | 2,071 | |
| other | Coronary artery disease | Cardiac disorders | No rIL-2 | 9 | 2,040 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rIL-2 | ||
| Total, all-cause mortality | No rIL-2 | ||
| Total, other adverse events | rIL-2 | 133 | 2,071 |
| Total, other adverse events | No rIL-2 | 92 | 2,040 |
| Total, serious adverse events | rIL-2 | 466 | 2,071 |
| Total, serious adverse events | No rIL-2 | 383 | 2,040 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI046957 | INTERNATIONAL PHASE III IL-2 STUDY | NEATON, JAMES DENNIS | UNIVERSITY OF MINNESOTA TWIN CITIES | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 1999 to 2005 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| rIL-2 vs No rIL-2: Pattern of Use of Prophylaxis for Opportunistic Infections | Trial comparisons |
| rIL-2 vs No rIL-2: Grade 4 Signs and Symptoms | Trial comparisons |
| rIL-2 vs No rIL-2: Number of Participants With Changes in Anti-retroviral Treatment (ART) | Trial comparisons |
| rIL-2 vs No rIL-2: Number of Participants Who Died From Any Cause | Trial comparisons |
| rIL-2 vs No rIL-2: Hepatic, Metabolic, and Cardiac Conditions | Trial comparisons |
| rIL-2 vs No rIL-2: New or Recurrent Serious HIV Disease Progression Event Including Death | Trial comparisons |
| rIL-2 vs No rIL-2: New or Recurrent HIV Disease Progression Event Including Death | Trial comparisons |
| rIL-2 vs No rIL-2: Participants With a New Disease Progression Event or Death | Trial comparisons |
| rIL-2 vs No rIL-2: 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/NCT00004978
GET https://conductscience.org/api/trials/v1/NCT00004978/events?page=2