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Jorge A. Tavel, MD On behalf of the STALWART Protocol Team of the INSIGHT Network

Study of Aldesleukin with and without Antiretroviral Therapy. Jorge A. Tavel, MD On behalf of the STALWART Protocol Team of the INSIGHT Network 5 th IAS Conference on HIV Pathogenesis, Treatment and Prevention 19-22 July 2009. STALWART Study Design.

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Jorge A. Tavel, MD On behalf of the STALWART Protocol Team of the INSIGHT Network

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  1. Study of Aldesleukin with and without Antiretroviral Therapy Jorge A. Tavel, MD On behalf of the STALWART Protocol Team of the INSIGHT Network 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention 19-22 July 2009

  2. STALWART Study Design Patients ART-naïve (or off ART ≥ 1year) with CD4+ T cells ≥ 300 /mm3 Control No IL-2 or ART IL-2+ IL-2 with peri-cycle ART IL-2 IL-2 alone N=91 N=87 N=89 Follow-up: Every 4 weeks until week 32, q 4 mo. thereafter Primary Endpoint: CD4+ cell count at week 32

  3. IL-2 Cycles • Subcutaneous injections twice daily for 5 consecutive days • Starting dose 7.5 MIU; reduce in decrements of 1.5 MIU as necessary to control toxicities • 3 cycles, 8 weeks apart

  4. Peri-cycle ART in the IL-2+ group ≥ 1 PI and ≥ 2 nRTIs IL-2 Cycle 1 2 days 5 days 14 days Subsequent Cycles 3 days 2 days 5 days

  5. STALWART Study Closure • Two large HIV studies, ESPRIT and SILCAAT, were unblinded January 8, 2009 • IL-2 did not result in a reduction of opportunistic disease or mortality but was associated with an increased risk of adverse events • Because of these findings: • STALWART IL-2 cycling was stopped • STALWART results were unblinded early • Planned follow-up ended February 28, 2009

  6. Participant Characteristics

  7. Frequency of Cycling At least 3 cycles: IL-2 76% IL-2+ 67% Percent

  8. IL-2 with or without peri-cycle ART increases CD4+ cell counts IL-2+ IL-2 CD4+ Control Study Week

  9. CD4+ Changes from Baseline to Week 32

  10. A greater number of participants assigned to no therapy started ART

  11. HIV RNA (log10) Changes from Baseline to Week 32

  12. IL-2 use is associated with a greater number of adverse events Patients with Events HR (95% CI) Event HR p = .03 p < .001 Favors Control ► ► Favors IL-2

  13. Opportunistic Events and Deaths

  14. SUMMARY • The groups assigned to receive IL-2: • Experienced CD4+ cell count increases • Started continuous ART less frequently • Experienced a greater number of opportunistic events or deaths • Combined with the results of ESPRIT and SILCAAT, this calls into question the functionality of CD4+ cells induced by IL-2

  15. STALWART PROTOCOL TEAM ICC Representatives Washington Barbara Standridge Copenhagen Daniela Gey London Nick Paton, Nicki Smith Sydney Cate Carey, David Courtney-Rodgers Statisticians Abdel Babiker Deb Wentworth SDMC Coordinator Nicole Wyman Community Rep Dave Munroe Protocol Clinicians Gustavo Lopardo Norm Markowitz Juan Carlos Lopez Kiat Ruxrungtham Martin Fisher

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