(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Active AIDS defining opportunistic infection or other active intercurrent illness is excluded if ongoing treatment requires the use of excluded concomitant medication.

Patients with symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with current neoplasms not specifically allowed.

Severe AIDS dementia complex defined by a score of \< 23 on the Mini-Mental State Exam.

Signs, symptoms, or history of peripheral neuropathy.

Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct, or history of angina or ischemia changes on ECG (electrocardiography).

Requiring \> 2 weeks of acyclovir therapy at \> 600 mg/day.

Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) not specifically allowed.

Significant liver disease.

Concurrent Medication:

Excluded:

Drugs that cause peripheral neuropathy:

chloramphenicol, cisplatinum, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, ribavirin, metronidazole, vincristine, nitrofurantoin.

Drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC), including experimental drugs not specifically allowed.

Drugs that could cause seizures or changes in mental status or neurological examination.

Concurrent Treatment:

Excluded:

Transfusion dependency.

Patients with the following are excluded:

Active AIDS defining opportunistic infection or other active intercurrent illness if ongoing treatment requires use of excluded concomitant medication.

Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or current neoplasms not specifically allowed.

Severe AIDS dementia complex defined by a score of \< 23 on the Mini-Mental State Exam.

Signs, symptoms, or history of peripheral neuropathy.

Unwilling or unable to sign informed consent.

Prior Medication:

Excluded:

Zidovudine (AZT), dideoxycytidine (ddC), or any other antiretroviral nucleoside analog.

Excluded within 90 days of study entry:

Any experimental drug including fluconazole, ganciclovir, foscarnet, erythropoietin, or ribavirin.

Excluded within 90 days of study entry:

Drugs that have caused significant nephrotoxicity or significant hepatotoxicity.

Drugs that could cause peripheral neuropathy including phenytoin, hydralazine, metronidazole, and nitrofurantoin.

Systemic corticosteroids or immunomodulators including interferon and interleukin.

Prior Treatment:

Excluded within 30 days of study entry:

Radiation therapy.

Active substance or alcohol abuse.

What this study is about