Trial Outcomes & Findings for 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 NCT00071890)

NCT ID: NCT00071890

Last Updated: 2010-10-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 148 participants
• Primary outcome timeframe: week 72
• Results posted on: 2010-10-05

Participant Flow

From November 2003 to July 2006, 148 patients were randomized (81 in the IL-2 arm and 67 in the control arm in one centre of the NIH (USA) and 21 centres of the ANRS network (France).

31 patients were not included because : CD4 below 500 (n=8), patient decision (n=6), HIV RNA < 50 copies/ml (n=5), neutropenia or high bilirubin(n=3), CD4 nadir below 200 (n=2),other diseases (n=2), AIDS (n=1), other reason (n=4)

Participant milestones

Measure	Interleukin-2 Group HAART and tree cycles of IL-2	Control Group HAART alone (without Interleukin-2)
Overall Study STARTED	81	67
Overall Study COMPLETED	81	67
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Interleukin-2 Group n=81 Participants HAART and tree cycles of IL-2	Control Group n=67 Participants HAART alone (without Interleukin-2)	Total n=148 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	66 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	42 years STANDARD_DEVIATION 8 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=7 Participants	43 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	54 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment France	77 participants n=5 Participants	63 participants n=7 Participants	140 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
CD4 at inclusion	770 cells per mm3 n=5 Participants	735 cells per mm3 n=7 Participants	747 cells per mm3 n=5 Participants
CD4 nadir	326 cells per mm3 n=5 Participants	328 cells per mm3 n=7 Participants	326 cells per mm3 n=5 Participants

PRIMARY outcome

Timeframe: week 72

Population: Intent to treat analysis, missing = failure.

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

Outcome measures

Measure	Interleukin-2 Group n=81 Participants HAART and tree cycles of IL-2	Control Group n=67 Participants HAART alone (without Interleukin-2)
Proportion of Patients Without Failure of Strategy From Week 0 to Week 72	73 Pourcentage Interval 63.0 to 83.0	55 Pourcentage Interval 43.0 to 67.0

SECONDARY outcome

Timeframe: week 72

Outcome measures

Measure	Interleukin-2 Group n=81 Participants HAART and tree cycles of IL-2	Control Group n=67 Participants HAART alone (without Interleukin-2)
Changes in CD4 Counts at Week 72	541 cells per mm3 Interval 398.0 to 702.0	453 cells per mm3 Interval 379.0 to 580.0

SECONDARY outcome

Timeframe: Overall study

Population: * IL-2 arm : Oesophageal candidasis at W196 * Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104

AIDS defined events according to CDC classification

Outcome measures

Measure	Interleukin-2 Group n=81 Participants HAART and tree cycles of IL-2	Control Group n=67 Participants HAART alone (without Interleukin-2)
AIDS Events	1 event	3 event

Adverse Events

Interleukin-2 Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr G. Chene

INSERM U897 Bordeaux FRANCE

Phone: 557571392

Email: genevieve.chene@isped.u-bordeaux2.fr

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results with no delay specified
• Publication restrictions are in place

Restriction type: OTHER