Concomitant therapy with subcutaneous interleukin-2 and zidovudine plus didanosine in patients with early stage HIV infection

Cecilia Simonelli, Stefania Zanussi, Simonetta Sandri, Manola Comar, Antonio Lucenti, Renato Talamini, Maria Teresa Bortolin, Mauro Giacca, Paolo De Paoli, Umberto Tirelli

Research output: Contribution to journalArticle

Abstract

A phase II study was performed to evaluate the feasibility and activity of subcutaneous (sc) interleukin-2 (IL-2) administration plus zidovudine (ZDV) and didanosine (ddI) in patients with early stage HIV infection. Between October 1995 and October 1996, 12 patients completed 6 cycles of the following scheduled therapy: ZDV plus ddI and SC self-administration of 6 mIU of IL-2 at days 1 to 5 and 8 to 12 of a 28-day cycle for a total of 6 cycles (24 weeks). After 6 cycles, patients received only ZDV plus ddI and they were observed up for an additional 24 weeks. Our schedule was well tolerated as an outpatient regimen and led to a significant elevation in CD4 count, which lasted for 24 weeks after the end of IL-2 therapy. Moreover, CD4/CD25, as well as CD4/CD45RO and CD4/CD45RA, cell levels were significantly increased at the end of the therapy and remained significantly elevated after 24 weeks. During the 6 cycles, HIV-associated viremia was significantly decreased and, accordingly, we observed a significant decline of proviral DNA in peripheral blood mononuclear cells (PBMCs). During follow-up, 10 of 12 treated patients continued to show levels of HIV-related viremia

Original languageEnglish
Pages (from-to)20-27
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume20
Issue number1
Publication statusPublished - Jan 1 1999

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Keywords

  • Concomitant therapy
  • Didanosine
  • Early stage HIV infection
  • Interleukin-2
  • Zidovudine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Virology

Cite this

Simonelli, C., Zanussi, S., Sandri, S., Comar, M., Lucenti, A., Talamini, R., Bortolin, M. T., Giacca, M., De Paoli, P., & Tirelli, U. (1999). Concomitant therapy with subcutaneous interleukin-2 and zidovudine plus didanosine in patients with early stage HIV infection. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, 20(1), 20-27.