30575
document
Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome ( AIDS ) /AIDS-related complex . To evaluate the effect of recombinant granulocyte-macrophage colony-stimulating factor ( GM-CSF ) on patients with acquired immunodeficiency syndrome ( AIDS ) or AIDS-related complex ( ARC ) who were intolerant to zidovudine because of neutropenia , we performed a randomized , open-label study in which patients were assigned to one of two groups . Zidovudine was discontinued in group A patients before instituting GM-CSF treatment and was restarted in a graduated fashion over 4 weeks . Group B patients continued on full-dose ( 1,200 mg/d ) zidovudine therapy while beginning GM-CSF therapy . A total of 17 patients were entered , eight in group A and nine in group B . Five of eight patients in group A and seven of nine in group B had a history of Pneumocystis carinii pneumonia ( PCP ) . All were homosexual males , except one female in group A who was the sex partner of a bisexual male with AIDS . All patients had neutropenia ( absolute neutrophil count [ ANC ] less than 1,000/microL ) while taking full-dose zidovudine . The mean CD4 ( +/- SD ) lymphocyte level was 37 ( +/- 29 ) /microL and 39 ( +/- 44 ) /microL in groups A and B , respectively . After randomization , patients were begun on subcutaneous GM-CSF at a dose of 1.0 microgram/kg/d . Patients in group A received 2 weeks of daily GM-CSF , at which time zidovudine was restarted if the ANC was greater than 1,000/microL ; if the ANC was less than 1,000/microL , the dose of GM-CSF was increased to 3.0 micrograms/kg , and at 2-week intervals either zidovudine was restarted or the dose of GM-CSF was increased to 5 micrograms/kg and then 10 micrograms/kg , to maintain the ANC greater than 1,000/microL . Group B patients received full-dose zidovudine concurrently with GM-CSF administration . The dose of GM-CSF was increased every 2 weeks if necessary to keep the ANC greater than 1,000/microL while maintaining full-dose zidovudine therapy . Patients in each group showed an increase in total white blood cell ( WBC ) count . Neutrophils and eosinophils were responsible for the majority of this increase . Patients in group A had a more rapid increase in WBC than those in group B ; however , by week 8 , the WBC in each group was essentially equal . Viral replication as measured by human immunodeficiency virus ( HIV ) p24 antigen ( Ag ) was decreased in four patients in each group , increased in one patient in each group , and remained unchanged in the remainder . The ability to culture virus from peripheral blood mononuclear cells was not changed by the regimen . The major toxicities of the regimen were fever and malaise . ( ABSTRACT TRUNCATED AT 400 WORDS )
30576
Intervention_Pharmacological
granulocyte-macrophage colony-stimulating factor
30577
Intervention_Pharmacological
GM-CSF
30578
Intervention_Pharmacological
GM-CSF treatment
30579
Intervention_Pharmacological
full-dose ( 1,200 mg/d ) zidovudine therapy
30580
Intervention_Physical
GM-CSF therapy
30581
Outcome_Other
effect
30582
Outcome_Physical
neutropenia
30583
Outcome_Physical
ANC
30584
Outcome_Physical
total white blood cell ( WBC ) count
30585
Outcome_Physical
Neutrophils and eosinophils
30586
Outcome_Physical
increase in WBC
30587
Outcome_Physical
WBC
30588
Outcome_Physical
Viral replication
30589
Outcome_Physical
human immunodeficiency virus ( HIV ) p24 antigen ( Ag )
30590
Outcome_Other
ability to culture virus
30591
Participant_Condition
acquired immunodeficiency syndrome ( AIDS ) /AIDS-related complex
30592
Participant_Condition
acquired immunodeficiency syndrome ( AIDS )
30593
Participant_Condition
AIDS-related complex ( ARC )
30594
Participant_Condition
neutropenia
30595
Participant_Sample-size
17
30596
Participant_Sample-size
Five
30597
Participant_Sample-size
eight
30598
Participant_Sample-size
seven
30599
Participant_Sample-size
nine
30600
Participant_Condition
Pneumocystis carinii pneumonia ( PCP )
30601
Participant_Sex
males
30602
Participant_Sex
female
30603
Participant_Condition
male
30604
Participant_Condition
AIDS
30605
Participant_Condition
neutropenia