Interferon-α2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: An AIDS malignancy consortium phase I trial

Susan E. Krown, Jeannette Y. Lee, Lan Lin, Margaret A. Fischl, Richard Ambinder, Jamie H. Von Roenn

Research output: Contribution to journalArticlepeer-review

37 Scopus citations

Abstract

We evaluated the safety and maximum tolerated dose of interferon (IFN)-α2b in combination with protease inhibitor-based highly active antiretroviral therapy (HAART) in a phase 1 study in 14 patients with AIDS-associated Kaposi sarcoma (KS). Planned IFN dose levels were 0, 1, 5, 10, and 15 million IU administered by daily subcutaneous injection. Dose-limiting toxicities were neutropenia and malaise. The maximum tolerated IFN dose was 5 million IU/d. The median CD4 count increased from 260 cells/μL at baseline to a maximum on-study value of 359 cells/μL. In 6 patients with paired baseline and on-study values, the median HIV RNA level decreased from 20,179 copies/mL to a minimum on-study value of 309 copies/mL. Of 13 patients whose KS response could be evaluated, 5 showed objective tumor regression. Responses occurred in HAART-experienced and HAART-naive subjects. Five patients, including 2 responders, 2 with stable KS, and 1 with progression, had serial measurements of Kaposi sarcoma herpesvirus (KSHV) load. None of these patients, irrespective of treatment arm or KS response, showed durable clearance of KSHV from plasma or peripheral blood mononuclear cells. This study establishes a safe dose of IFN that can be used with HAART and, potentially, with other inhibitors of KS in future clinical trials.

Original languageEnglish (US)
Pages (from-to)149-153
Number of pages5
JournalJournal of Acquired Immune Deficiency Syndromes
Volume41
Issue number2
DOIs
StatePublished - Feb 2006

Keywords

  • Highly active antiretroviral therapy
  • Interferon-α
  • Kaposi sarcoma
  • Kaposi sarcoma herpesvirus

ASJC Scopus subject areas

  • Virology
  • Immunology

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