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A Randomized Controlled Clinical Trial—AIDS Clinical Trials Group 328

Ronald Mitsuyasu, MD; Rebecca Gelman, PhD; Deborah Weng Cherng, MS; Alan Landay, PhD; John Fahey, MD; Richard Reichman, MD; Alejo Erice, MD; R. Pat Bucy, MD, PhD; J. Michael Kilby, MD; Michael M. Lederman, MD; Carol D. Hamilton, MD; Juan Lertora, MD, PhD; Becky L. White, MD; Pablo Tebas, MD; Anne-Marie Duliege, MD; Richard B. Pollard, MD; for the AIDS Clinical Trials Group 328 Study Team

Arch Intern Med. 2007;167(6):597-605.

Background  Interleukin 2 (IL-2) administration increases CD4 counts in persons with higher counts. This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy (HAART).

Methods  Two hundred four patients with CD4 T-cell counts from 50/µL to 350/µL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen. Virologic responders (5000 copies/mL) at 12 weeks were randomized to open-label continuous-infusion IL-2 (IV IL-2), subcutaneous IL-2 (SC IL-2), or HAART alone. Thirty were not randomized and 15 enrolled in a substudy, leaving 159 for analysis. Subjects continued HAART alone for 72 weeks (n = 52) or with IV IL-2 (n = 53) or SC IL-2 (n = 54) for 5 days every 8 weeks. The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/µL or by 25%.

Results  Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts. At week 84, median increases were 459/µL, 312/µL, and 102/µL. Increases of greater than 50% at week 60 (primary end point) were achieved in 39 patients (81%) and 32 (67%) in the IV and SC IL-2 arms, respectively, compared with 13 (29%) in the HAART arm (P<.001 for both). Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels. There were fewer new AIDS-defining events in the IV (P = .006) and SC (P = .03) IL-2 groups than in the HAART group (0, 1, and 7, respectively). Drug-related adverse events were more frequent with IL-2 treatment.

Conclusion  Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection, without loss of virologic control.

Author Affiliations: Departments of Internal Medicine, University of California–Los Angeles (UCLA) (Dr Mitsuyasu), University of Rochester, Rochester, Minn (Dr Reichman), University of Minnesota, Minneapolis (Dr Erice), University of Alabama at Birmingham (Dr Kilby), Case Western Reserve University, Cleveland, Ohio (Dr Lederman), Duke University, Durham, NC (Dr Hamilton), University of North Carolina, Winston-Salem (Dr White), and Washington University, St Louis, Mo (Dr Tebas); Dana-Farber Cancer Center, New York, NY (Dr Gelman); Department of Epidemiology, Harvard School of Public Health, Boston, Mass (Dr Gelman and Ms Cherng); Department of Microbiology and Immunology, Rush University Medical Center, Chicago, Ill (Dr Landay); Department of Microbiology, UCLA (Dr Fahey); Department of Pathology, University of Alabama at Birmingham (Dr Bucy); Department of Pharmacology, Tulane University, New Orleans, La (Dr Lertora); Chiron Corporation, Emeryville, Calif (Dr Duliege); and Division of Infectious Diseases, Department of Internal Medicine, University of California–Davis (Dr Pollard). A list of the participating members of the AIDS Clinical Trials Group 328 Study Team is given in the Acknowledgments.

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