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1994-08-27
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Document 0730
DOCN M9480730
TI The duration of zidovudine benefit in persons with asymptomatic HIV
infection. Prolonged evaluation of protocol 019 of the AIDS Clinical
Trials Group.
DT 9410
AU Volberding PA; Lagakos SW; Grimes JM; Stein DS; Balfour HH Jr; Reichman
RC; Bartlett JA; Hirsch MS; Phair JP; Mitsuyasu RT; et al; University of
California-San Francisco.
SO JAMA. 1994 Aug 10;272(6):437-42. Unique Identifier : AIDSLINE
MED/94315721
AB OBJECTIVE--To determine the durability of zidovudine-induced delay in
clinical progression of asymptomatic human immunodeficiency virus (HIV)
disease and to assess the relationship between this effect and the entry
CD4+ cell count. DESIGN AND INTERVENTIONS--Extended follow-up data from
subjects participating in protocol 019 of the AIDS [acquired
immunodeficiency syndrome] Clinical Trials Group were examined. Subjects
were offered a total daily dose of 500 mg of open-label zidovudine after
the unblinding of the original randomized trial in 1989. Original
treatment groups included placebo, 500 mg of zidovudine, or 1500 mg of
zidovudine daily in divided doses. Three distinct analyses were
conducted to assess the duration of zidovudine's effect on progression
to AIDS or death: (1) analysis of all follow-up information from all
subjects, (2) analysis of all subjects but with follow-up of original
placebo-assigned subjects censored at the time open-label zidovudine was
initiated, and (3) analysis of the effect of initiating zidovudine in
subjects initially assigned to receive placebo.
SETTING--University-based and university-affiliated AIDS research
clinics participating in AIDS Clinical Trials Group protocol 019.
PATIENTS--A total of 1565 asymptomatic HIV-infected subjects with entry
CD4+ cell counts less than 0.50 x 10(9)/L (500/microL). MAIN OUTCOME
MEASURE--Time to progression to AIDS or death. RESULTS--During follow-up
of up to 4.5 years (mean, 2.6 years), 232 subjects progressed to AIDS or
died. In each of the three analyses described herein, zidovudine was
associated with a significant (P = .008, .004, .007) decrease in the
risk of such progression. However, each of these analyses also indicated
a decreasing placebo:zidovudine relative risk with duration of use (P =
.002, .08, .04), suggesting a nonpermanent effect. The duration of
benefit appeared to be related to entry CD4+ cell count, with greater
benefit in those with higher counts at entry. No significant differences
in survival were found between those originally randomized to zidovudine
or placebo. CONCLUSIONS--Zidovudine at 500 mg/d caused a significant
delay in progression to AIDS or death, but its earlier use in
asymptomatic disease was not associated with an additional prolongation
of survival compared with delayed initiation. The delay in progression
diminished over time especially in subjects with entry CD4+ cell counts
less than 0.30 x 10(9)/L (300/microL). Treatment strategies that alter
drug regimens before the loss of zidovudine benefit should be explored.
DE Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL Adult Clinical
Protocols Follow-Up Studies Human HIV Infections/*DRUG
THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY Leukocyte Count Male Middle Age
Proportional Hazards Models Support, Non-U.S. Gov't Survival Analysis
T4 Lymphocytes Zidovudine/*THERAPEUTIC USE CLINICAL TRIAL JOURNAL
ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).