A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment.

TitleA randomized trial of interleukin-2 during withdrawal of antiretroviral treatment.
Publication TypeJournal Article
Year of Publication2011
AuthorsBosch RJ, Pollard RB, Landay A, Aga E, Fox L, Mitsuyasu R
Corporate AuthorsAIDS Clinical Trials Group A5132 Team
JournalJ Interferon Cytokine Res
Volume31
Issue6
Pagination481-3
Date Published2011 Jun
ISSN1557-7465
KeywordsAdjuvants, Immunologic, Antiretroviral Therapy, Highly Active, Clinical Protocols, Female, Follow-Up Studies, HIV, HIV Infections, Humans, Immunotherapy, Interleukin-2, Male, Middle Aged, RNA, Viral, Virus Replication, Withholding Treatment
Abstract

In HIV-infected individuals on antiretroviral treatment with viral suppression, structured treatment interruptions are designed to allow exposure to endogenous HIV antigens and to thereby boost HIV-specific immunity. AIDS Clinical Trials Group A5132 was an exploratory 2-arm randomized trial that evaluated two 4-week treatment interruptions in combination with 2 strategies for administering interleukin-2 (IL-2): 2.0 million international units of IL-2 subcutaneously daily during the final 2 weeks of treatment interruption and the first week of treatment reinitiation (arm A), or 4.5 million international units of IL-2 subcutaneously twice a day during the first 5 days of treatment reinitiation (arm B). Twenty-one subjects with HIV-1 RNA <50 copies/mL and CD4+ T cell counts ≥300 (median 615) cells/mm(3) were randomized. The primary endpoint was the viral setpoint measured 11-12 weeks after a third treatment interruption (observed for 7 Arm A and 9 Arm B). The median HIV-1 RNA setpoints were 4.3 and 4.5 log(10) copies/mL for Arm A and Arm B, respectively; there was no evidence of a difference between arms (P = 0.50, rank-sum test, worst rank for unobserved viral setpoint). The current study, the first to evaluate IL-2 during repeated short-term treatment interruptions, revealed no evidence for augmentation of HIV immunity. Viral setpoints were similar to historical controls, emphasizing the need for new strategies to enhance HIV-specific immunity.

DOI10.1089/jir.2010.0119
Alternate JournalJ. Interferon Cytokine Res.
PubMed ID21291323
PubMed Central IDPMC3104401
Grant ListAI 32782 / AI / NIAID NIH HHS / United States
AI 38855 / AI / NIAID NIH HHS / United States
AI 38858 / AI / NIAID NIH HHS / United States
AI 68634 / AI / NIAID NIH HHS / United States
AI 68636 / AI / NIAID NIH HHS / United States
AI 69477 / AI / NIAID NIH HHS / United States
AI 69556 / AI / NIAID NIH HHS / United States