Phase 3
N=4,150
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00004978 ↗Enrolled (actual)
4,150
Serious AEs
20.7%
Results posted
Apr 2011
Primary outcome: Primary: New or Recurrent HIV Disease Progression Event Including Death — 159; 165 participants — p=.55
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Recombinant interleukin-2 (rIL-2) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New or Recurrent HIV Disease Progression Event Including Death |
159; 165 | .55 |
| SECONDARY New or Recurrent Serious HIV Disease Progression Event Including Death |
126; 130 | .62 |
| SECONDARY Number of Participants Who Died From Any Cause |
107; 116 | .42 |
| SECONDARY Participants With a New Disease Progression Event or Death |
154; 164 | .41 |
| SECONDARY Absolute CD4 Cell Counts Averaged Throughout Followup |
715.4; 556.3 | — |
| SECONDARY Plasma HIV RNA Levels |
2.20; 2.17 | — |
| SECONDARY Number of Participants With Changes in Anti-retroviral Treatment (ART) |
1760; 1751 | .07 |
| SECONDARY Grade 4 Signs and Symptoms |
466; 383 | .003 sig |
| SECONDARY Pattern of Use of Prophylaxis for Opportunistic Infections |
54; 53 | .97 |
| SECONDARY Hepatic, Metabolic, and Cardiac Conditions |
134; 136 | .74 |
Summary
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.
Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
Eligibility Criteria
Inclusion Criteria
- HIV positive
- Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry
- Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of study entry
- Are at least 18 years old
Exclusion Criteria
- Have received IL-2 before
- Have cancer requiring chemotherapy
- Have evidence of active clinical disease within the past year for any AIDS-defining illness or certain other conditions such as herpes zoster or Chagas disease. (This study has been changed. Previously, patients were ineligible if they had a history of any AIDS-defining illness or certain other conditions.)
- Have used certain medications, such as corticosteroids or drugs affecting the immune system, in the 45 days before study entry
- Have a nervous system disorder requiring antiseizure medication
- Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications
- Are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00004978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.