Combination of ganciclovir and granulocyte-macrophage colony-stimulating factor in the treatment of cytomegalovirus retinitis in AIDS patients. The ACTG 073 Team.
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)
Hardy
D
D
AIDS Clinical Research Center, University of California, Los Angeles 90024-1793.
Spector
S
S
Polsky
B
B
Crumpacker
C
C
van der Horst
C
C
Holland
G
G
Freeman
W
W
Heinemann
M H
MH
Sharuk
G
G
Klystra
J
J
D017088:AIDS-Related Opportunistic Infections / Q000150:complications*; D000328:Adult; D017726:Cytomegalovirus Retinitis / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy; D006801:Humans; D008297:Male; D009503:Neutropenia / Q000188:drug therapy / Q000209:etiology; D011379:Prognosis; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use
D015215:Zidovudine; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D015774:Ganciclovir