HIV Infections Clinical Trial
Official title:
Dideoxycytidine (Ro 24-2027). An Open-Label, Safety Study of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine (AZT) Therapy
AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment
with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate
that ddC monotherapy is safe, and tolerable in this patient population.
Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or
advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to
zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that
ddC monotherapy is safe and tolerable in the treatment of patients who previously
experienced either treatment failure, hematologic intolerance or myositis with AZT treatment
and pancreatitis or other toxicities (except peripheral neuropathy with ddI).
The first 50 patients enrolled into the study will be with investigators having prior ddC
experience, specifically AIDS Clinical Trials Group (ACTG), or non-ACTG investigators who
are listed in ddC protocols NIAID ACTG 012, 112, 047, 050, 106 (N3447), 114 (N3300), 119
(N3492), N3226, or investigators at any ACTG center or ACTG satellite centers with knowledge
of ddC therapy.
Once all 50 patients have been entered and 25 have completed four weeks of treatment the
study will be dependent upon receipt of completed case forms up to week #4 of treatment for
the 25 patients who have been reviewed and evaluated for safety.
Patients 51-200 may then be entered by any physician licensed in his or her state who has
experience with AIDS patients and agrees to follow the patients as specified in the
protocol. After all 200 have been entered and week #16 case report forms are returned to the
ddC Coordinating Center and reviewed for safety for 100 of the 200 patients, the protocol
would be open without limit on numbers of patients.
;
Masking: Open Label, Primary Purpose: Treatment
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