Trial · NCT00071890
Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx
NCT00071890, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2010-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx. Trials, record NCT00071890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00071890
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx
- NCT number
- NCT00071890
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Interleukin 2, HAART, Treatment interruption
- First posted
- 2003-11-04
- Last updated
- 2010-10-05
- Results first posted
- 2010-10-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Without Failure of Strategy From Week 0 to Week 72 | week 72 | A failure of strategy is defined on the first occurrence of one of the following events: * CD4 T-lymphocyte count becomes \< 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks * Planned interruption of therapy at Wk24 cannot be done for any reason; * Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason * Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I) * Subject expires between Wk0 and Wk72 (whatever the cause of death) * Subject is lost to follow up |
| Secondary | Changes in CD4 Counts at Week 72 | week 72 | |
| Secondary | AIDS Events | Overall study | AIDS defined events according to CDC classification |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Without Failure of Strategy From Week 0 to Week 72 | week 72 | Intent to treat analysis, missing = failure. | Pourcentage | NUMBER |
| SECONDARY | Changes in CD4 Counts at Week 72 | week 72 | cells per mm3 | MEDIAN | |
| SECONDARY | AIDS Events | Overall study | * IL-2 arm : Oesophageal candidasis at W196~* Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104 | event | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Without Failure of Strategy From Week 0 to Week 72 | Interleukin-2 Group | 73 | 95% Confidence Interval 63 to 83 | Pourcentage | |
| Proportion of Patients Without Failure of Strategy From Week 0 to Week 72 | Control Group | 55 | 95% Confidence Interval 43 to 67 | Pourcentage | |
| Changes in CD4 Counts at Week 72 | Interleukin-2 Group | 541 | Inter-Quartile Range 398 to 702 | cells per mm3 | |
| Changes in CD4 Counts at Week 72 | Control Group | 453 | Inter-Quartile Range 379 to 580 | cells per mm3 | |
| AIDS Events | Interleukin-2 Group | 1 | event | ||
| AIDS Events | Control Group | 3 | event |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interleukin-2 Group | 81 | |
| Overall Study | STARTED | Control Group | 67 | |
| Overall Study | COMPLETED | Interleukin-2 Group | 81 | |
| Overall Study | COMPLETED | Control Group | 67 | |
| Overall Study | NOT COMPLETED | Interleukin-2 Group | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interleukin-2 Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Interleukin-2 Group | 0 | 0 |
| Total, other adverse events | Control Group | 0 | 0 |
| Total, serious adverse events | Interleukin-2 Group | 0 | 0 |
| Total, serious adverse events | Control Group | 0 | 0 |
Source ClinicalTrials.gov
Papers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00071890
GET https://conductscience.org/api/trials/v1/NCT00071890/registered