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Placebo-controlled trial to evaluate zidovudine in treatment of human
immunodeficiency virus infection in asymptomatic patients with hemophilia.
NHF-ACTG 036 Study Group
TC Merigan, DA Amato, J Balsley, M Power, WA Price, S Benoit, A Perez-Michael, A Brownstein, AS Kramer and D Brettler
Center for AIDS Research, Stanford University School of Medicine, CA.
One hundred ninety-three asymptomatic patients with hereditary coagulation
disorders and human immunodeficiency virus (HIV) infection were studied in
a controlled trial of zidovudine (ZDV) versus a placebo (with an average of
9.7 months on study). Pretreatment characteristics were well balanced
between the placebo and drug-treated groups, including CD4 distributions,
types of clotting disorders, transaminase abnormalities, and use of various
hemostatic agents. At the time of analysis, 161 patients either were still
receiving treatment or had previously reached an endpoint of disease
progression while receiving treatment. Twenty-five patients withdrew
voluntarily. The toxic effects noted included granulocytopenia and anemia,
especially in older patients, and subjective symptoms of asthenia, malaise,
and nausea, consistent with the known consequences of treatment with 300 mg
ZDV five times daily. There was a trend toward more diagnoses of acquired
immunodeficiency syndrome (AIDS), advanced or early AIDS-related complex
(ARC), single ARC symptoms, or death in placebo recipients as compared with
those receiving ZDV (22 v 13). Because older patients with hemophilia have
more rapid disease progression, the same efficacy analysis was performed in
the 89 patients aged more than 30 years who were receiving treatment. In
this subgroup, there was a similar trend (11 v 6). With regard to the most
advanced problems of the infection among the older patients, there were
five patients who were newly diagnosed with AIDS or died in the placebo
group versus none in the ZDV group (P = .02) among the older patients. The
pretreatment distribution of CD4 counts for the placebo and ZDV groups were
similar, but patients aged more than 30 years had significantly (P less
than .049) fewer CD4 cells than patients aged less than 30 years. A
beneficial ZDV effect is also supported by a trend toward higher CD4 counts
(a 48-cell increase in the ZDV group at 24 weeks as compared with a
four-cell increase in the placebo group) and a significant (P = .03)
difference in weight gain in the ZDV patients aged more than 30 years (8
pounds) as compared with the older placebo patients (aged more than 30
years) (2 pounds) at week 24. The findings in the asymptomatic hemophilic
patients aged more than 30 years support a useful effect of ZDV, which is
similar to observations in the larger study of its use in asymptomatic,
nonhemophilic patients.
Volume 78,
Issue 4,
pp. 900-906,
08/15/1991
Copyright © 1991 by The American Society of Hematology
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