Combination of ganciclovir and granulocyte-macrophage colony-stimulating factor in the treatment of cytomegalovirus retinitis in AIDS patients. The ACTG 073 Team.

  • Hardy D
  • Spector S
  • Polsky B
 et al. 
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Abstract

The efficacy and safety of a combination of ganciclovir plus GM-CSF was evaluated in AIDS patients with cytomegalovirus retinitis. In phase A, patients were randomized to receive ganciclovir, 5 mg/kg every 12 h for 14 days followed by 5 mg/kg daily, with (n = 24) or without (n = 29) GM-CSF (1-8 micrograms/kg daily subcutaneously) to maintain absolute neutrophil counts between 2500 and 5000 cells/microliters. In phase B, after 16 weeks zidovudine was added to the regimen of 16 patients receiving ganciclovir plus GM-CSF and 20 receiving ganciclovir alone. At this stage, GM-CSF was added to the treatment protocol of any patient receiving ganciclovir plus zidovudine who became neutropenic. In phase A, patients in the ganciclovir plus GM-CSF group had significantly higher neutrophil counts than ganciclovir-alone patients (p = 0.0001). Overall, 12.5% of patients treated with GM-CSF developed neutropenia (absolute neutrophil counts < 500/microliters phase A and < 750/microliters phase B) compared with 45% of patients treated without GM-CSF. GM-CSF patients missed 10 of a possible 4705 scheduled doses of ganciclovir compared with 34 missed doses of a possible 6584 in the ganciclovir-alone group (p = 0.011). There was a trend, although not statistically significant, for patients in the GM-CSF group to experience delayed progression of their retinitis.(ABSTRACT TRUNCATED AT 250 WORDS)

Author-supplied keywords

  • AIDS-Related Opportunistic Infections
  • Adult
  • Combination
  • Cytomegalovirus Retinitis
  • Drug Administration Schedule
  • Drug Interactions
  • Drug Therapy
  • Female
  • Ganciclovir
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • HIV Infections
  • Humans
  • Male
  • Neutropenia
  • Prognosis
  • Zidovudine
  • administration & dosage
  • adverse effects
  • complications
  • drug therapy
  • etiology
  • pharmacokinetics
  • therapeutic use

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Authors

  • D Hardy

  • S Spector

  • B Polsky

  • C Crumpacker

  • C van der Horst

  • G Holland

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