CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,150 enrolled
Drug / intervention
Recombinant interleukin-2 (rIL-2)drug
Likely dose
Recombinant interleukin-2 (rIL-2) 7.5 MIU subcutaneously twice daily for 5 consecutive days every 8 weeks for at least 3 cyclesAI-extracted
Key inclusion· 4
  • ✓HIV-1 positive
  • ✓CD4+ cell count ≥300 cells/mm³ within 45 days of study entry
  • ✓On combination antiretroviral therapy or beginning such therapy at study entry
  • ✓Age ≥18 years
Key exclusion· 7
  • ✕Prior IL-2 therapy
  • ✕Cancer requiring chemotherapy
  • ✕Active AIDS-defining illness or other conditions (herpes zoster, Chagas disease) within the past year
  • ✕Immunosuppressive medications (corticosteroids, immune-modulating drugs) within 45 days before study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004978
NCT00004978Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 5, 2021

In Brief

A Phase 3 clinical trial evaluating Recombinant interleukin-2 (rIL-2) for HIV Infections. Completed, enrolled 4,150 participants across 248 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
CollaboratorsChiron Corporation

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Enrollment StartMar 1, 2000
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 24.8 years ago

Interventions

Recombinant interleukin-2 (rIL-2)drug

Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.