An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
- Conditions
- HIV Infections
- Registration Number
- NCT00002265
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG 114) or N3492 (NIAID ACTG 119).
NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY:
Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC. Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator. Their use may be allowed with interruption of study drug for up to 35 days per episode, for a total of 90 days for the study. If the patient's condition requires chronic administration of these medications, the patient will be discontinued from study medication and followed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Dr Robert Swartz
🇺🇸Fort Myers, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Med Service
🇺🇸Miami, Florida, United States
Ctr for Special Immunology
🇺🇸Fort Lauderdale, Florida, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Davies Med Ctr
🇺🇸San Francisco, California, United States
Mount Zion Med Ctr
🇺🇸San Francisco, California, United States
Graduate Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Humana Hosp / Med City Dallas
🇺🇸Dallas, Texas, United States