Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16;:130.
Purpose: To compare the effectiveness and safety of ZDV vs DDI in pts on
ZDV for 6 months or more. Methods: Pts on ZDV for greater than or equal
to 6 mo, CD4 less than or equal to 300, and HIV disease progression,
were blindly assigned to receive ZDV 600 mg/day or DDI 500-750 mg/day.
Sixteen male pts were enrolled (10 with history of IVDA, 5 homosexuals
and 1 with HIV secondary to transfusion). Eight pts were assigned to
each treatment regime. Results: Pts enrolled: 16. Early terminated: 3
(2- DDI toxicity; 1- ZDV died - primary illness). Of the remaining 13
pts, 8 completed 7 mo. or more in study (8.3 mo.), 3 were discontinued
for poor compliance, and 2 were lost to F/U. Of the 8 pts that completed
the study (6/10 IVDA and 2/5 homosexuals), 5 were on DDI and 3 on ZDV.
One of the pts on ZDV developed pulmonary histo., his CD4 count dropped
from 80 to 20, and after treatment he survived and was crossover to DDI.
Pt is clinically stable (1/93). The remaining 7 pts that completed the
study had no O.I. nor clinical deterioration. Pts with entry mean CD4
count = 180 had better outcome than those with CD4 less than or equal to
90. Pts with entry CD4 less than 90 had greater than 50% decrease in
their CD4 counts (3 on ZDV, 1 on DDI). Pts on DDI and entry CD4 greater
than or equal to 100 had CD4s around entry levels for 7 mos. or more.
Conclusion: There is stabilization of illness and CD4 counts, and
decreased progression to opportunistic infection in HIV+ pts treated
with DDI after being on ZDV for 6 months or more. IVDAs were as reliable
or more than other HIV+ pts in this study.
Adult CD4 Lymphocyte Count Double-Blind Method Drug Therapy,
Combination Drug Tolerance Enzyme Inhibitors/ADMINISTRATION &
DOSAGE/*THERAPEUTIC USE Human HIV Core Protein p24/BLOOD HIV
Seropositivity/BLOOD/*DRUG THERAPY HIV-1/ENZYMOLOGY Male Middle Age
RNA-Directed DNA Polymerase/ANTAGONISTS & INHIB RNA, Viral/BLOOD
Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT