Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: ACTG 068

Donna Mildvan, Yiannis Bassiakos, Marcia L. Zucker, Newton Hyslop, Susan E. Krown, Henry S. Sacks, James Zachary, Josephine Paredes, W. Jeffrey Fessel, Frank Rhame, Francoise Kramer, Margaret A. Fischl, Bernard Poiesz, Kenneth Wood, Ruth M. Ruprecht, John Kim, Sidney E. Grossberg, Patricia Kasdan, Peter Bergé, Ann MarshakCarla Pettinelli

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

Thirty-four subjects with symptomatic HIV-1 infection, p24 antigenaemia, and CD4 cell counts > 200/mm3 were randomly assigned to receive treatment with either zidovudine (ZDV) orally, interferon-alpha (IFN-α) subcutaneously, or both at respective low (200 mg ZDV/2 million international units IFN-α (MIU)), middle (400 mg/4 MIU) or high (600 mg/6 MIU) daily dose levels for 12 weeks. Thereafter, all patients received combination therapy at the initially assigned dose level to a total of 96 weeks. This design permitted analysis by the combination index (CI) method, which demonstrated antiretroviral synergy between ZDV and IFN-α with respect to p24 antigen suppression. Over the first 12 weeks, combination therapy was acceptably tolerated, more so than IFN-α monotherapy, and it was significantly more active in suppressing antigenaemia than either of the monotherapies. Similarly, the high-dose combination was the most active dose level over weeks 12 to 96. Combination ZDV/IFN-α. at the optimal dose level defined by this trial merits further study. In addition, the CI design strategy employed here may be useful for the investigation of new antiretroviral combinations.

Original languageEnglish (US)
Pages (from-to)77-88
Number of pages12
JournalAntiviral Therapy
Volume1
Issue number2
StatePublished - Dec 1 1996

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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    Mildvan, D., Bassiakos, Y., Zucker, M. L., Hyslop, N., Krown, S. E., Sacks, H. S., Zachary, J., Paredes, J., Fessel, W. J., Rhame, F., Kramer, F., Fischl, M. A., Poiesz, B., Wood, K., Ruprecht, R. M., Kim, J., Grossberg, S. E., Kasdan, P., Bergé, P., ... Pettinelli, C. (1996). Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: ACTG 068. Antiviral Therapy, 1(2), 77-88.