At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection
- ✓CD4+ count ≥300 cells/mm³
- ✓Access to HAART regimen with ≥1 protease inhibitor and ≥2 nucleoside/nucleotide reverse transcriptase inhibitors
- ✕Prior use of aldesleukin (IL-2)
- ✕Approved or experimental antiretroviral drug (including hydroxyurea) within 1 year prior to study entry
- ✕Evidence of virologic failure on PI- or nonnucleoside-based HAART
- ✕Current indication for continuous HAART per investigator
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
STALWART: A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4+ Cell Counts of 300 Cells/mm3 or More
In Brief
A Phase 2 clinical trial evaluating IL-2 for HIV Infections. Completed, enrolled 267 participants across 36 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.
Study Details
Timeline
Interventions
7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)