HIV Infections Clinical Trial
Official title:
An Open-Label, Randomized, Dose-Finding, Multicenter Trial of Dideoxycytidine (ddC) Administered Concurrently With Zidovudine (AZT) in the Treatment of AIDS or Advanced ARC
To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine
(dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or
advanced AIDS-related complex (ARC).
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal
of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and
ddC may work together in a way that both drugs can be taken at lower doses or less frequent
intervals when given together. If the doses can be reduced, then toxicity associated with
long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the
likelihood of the emergence of resistant mutants. Recent studies indicate a reduced
sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical
significance of this finding is not clear, it would indicate that these combination studies
are all the more important. HIV strains with decreased sensitivity to AZT are still
sensitive to ddC.
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal
of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and
ddC may work together in a way that both drugs can be taken at lower doses or less frequent
intervals when given together. If the doses can be reduced, then toxicity associated with
long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the
likelihood of the emergence of resistant mutants. Recent studies indicate a reduced
sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical
significance of this finding is not clear, it would indicate that these combination studies
are all the more important. HIV strains with decreased sensitivity to AZT are still
sensitive to ddC.
Patients are randomly assigned to one of six treatment groups of various dose combinations
of AZT and ddC. Patients are evaluated every week for the first 10 weeks and biweekly
thereafter.
;
Primary Purpose: Treatment
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