HIV Infections Clinical Trial
Official title:
(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT)
in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a
different safety profile than AZT.
In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and
because of the low incidence of mild, reversible neurotoxicity and absence of blood-related
toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in
patients with AIDS or advanced ARC is now warranted.
In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and
because of the low incidence of mild, reversible neurotoxicity and absence of blood-related
toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in
patients with AIDS or advanced ARC is now warranted.
After screening, physical examination and laboratory tests (within 14 days of entry)
patients are randomized to one of two treatment groups. They receive either ddC plus an AZT
placebo or AZT plus a ddC placebo. Because it is a blinded study, patients do not know which
group they are in. Patients are evaluated weekly for the first 10 weeks and then biweekly
thereafter.
;
Masking: Double-Blind, Primary Purpose: Treatment
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