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document
Safety and efficacy of thymopentin in zidovudine ( AZT ) -treated asymptomatic HIV-infected subjects with 200-500 CD4 cells/mm3 : a double-blind placebo-controlled trial . Thymopentin , 50 mg subcutaneously ( s.c. ) 3 times per week , was evaluated in a double-blind , randomized , placebo-controlled trial of zidovudine ( AZT ) -treated asymptomatic human immunodeficiency virus ( HIV ) -infected subjects with 200-500 CD4 cells/mm3 at entry . The 352 subjects were prestratified by prior AZT use into stratum I ( 235 subjects , > 6 months AZT at entry ) and stratum II ( 117 subjects , < or = 6 months AZT at entry ) . Clinical end points , CD4 cell counts , serum p24 , serum immune complex dissociated ( ICD ) p24 , and safety variables were evaluated through 48 weeks , using an intent-to-treat analysis . The two strata were analyzed individually because they yielded different clinical outcomes , with a statistically significant treatment-by-stratum interaction . In stratum I ( mean , 16 months AZT at entry ) two AIDS or death events occurred in thymopentin and 10 in placebo recipients ( p = 0.024 ; relative risk ( RR ) estimate , 4.9 [ 95 % confidence limit ( CI ) , 1.1 to 22.2 ] ) . There were three AIDS-related complex ( ARC ) , AIDS , or death events in thymopentin and 18 in placebo recipients [ p = 0.001 ; RR estimate , 5.9 ( 95 % CI , 1.7 to 20.0 ) ] . In stratum II ( mean , 3 months AZT at entry ) , four AIDS or death events occurred in thymopentin and none in placebo recipients ( p = 0.11 ) , and four ARC , AIDS , or death events occurred in thymopentin and two in placebo recipients ( p = 0.79 ) . The treatment groups did not differ significantly with respect to changes in CD4 counts or p24 antigen levels or with respect to clinical adverse experiences or laboratory abnormalities . Thus , AZT-experienced placebo-treated subjects had relatively high progression rates to AIDS or death and to ARC , AIDS , or death , and these rates were reduced by thymopentin treatment . In contrast , placebo-treated subjects with little prior AZT experience had low progression rates ; these were not significantly changed by thymopentin treatment . There was no increase in the incidence of adverse reactions with thymopentin .
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Intervention_Pharmacological
Thymopentin
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Intervention_Control
placebo-controlled
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Intervention_Control
placebo
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Outcome_Other
Safety and efficacy of thymopentin
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Outcome_Physical
CD4 cell counts , serum p24 , serum immune complex dissociated ( ICD ) p24 ,
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Outcome_Other
safety variables
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Outcome_Mortality
AIDS or death events
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Outcome_Mortality
AIDS-related complex ( ARC ) , AIDS , or death events
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Outcome_Mortality
AIDS or death events
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Outcome_Mortality
ARC , AIDS , or death events
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Outcome_Physical
CD4 counts or p24 antigen levels
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Outcome_Adverse-effects
clinical adverse experiences
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Outcome_Adverse-effects
laboratory abnormalities .
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Outcome_Mortality
AIDS or death and to ARC , AIDS , or death
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Outcome_Adverse-effects
adverse reactions
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Participant_Condition
zidovudine ( AZT ) -treated asymptomatic HIV-infected subjects with 200-500 CD4 cells/mm3
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Participant_Condition
human immunodeficiency virus ( HIV ) -infected
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Participant_Sample-size
352