HIV Infections Clinical Trial
Official title:
Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.
To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine (
AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have
already received at least 1 year of AZT therapy and to define the safety profile.
ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease
mortality and to reduce the frequency of opportunistic infections in patients with AIDS or
advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients
progress with more opportunistic infections and higher mortality rates. This may be due to
the emergence of AZT resistant virus isolated from some patients who have been on long-term
AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness
of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is
warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated
with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be
diminished by decreased effectiveness of AZT.
ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease
mortality and to reduce the frequency of opportunistic infections in patients with AIDS or
advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients
progress with more opportunistic infections and higher mortality rates. This may be due to
the emergence of AZT resistant virus isolated from some patients who have been on long-term
AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness
of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is
warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated
with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be
diminished by decreased effectiveness of AZT.
AMENDED: AZT will be administered orally every 4 or 5 hours. Patients in the second arm
discontinue AZT and take ddC as two tablets every 8 hours. Duration of the study is 1 year
with interim analysis done at 6 months after 75 percent enrollment and at end of the study.
Original design: Patients with AIDS or advanced ARC who have been receiving at least 500
mg/day of AZT for at least 48 weeks are randomized to 1 of 2 treatment arms. Patients in the
first treatment arm continue their current dose of AZT.
;
Masking: Open Label, Primary Purpose: Treatment
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