(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
- Conditions
- HIV Infections
- Registration Number
- NCT00000679
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
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 (25)
Graduate Hosp
🇺🇸Philadelphia, Pennsylvania, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Ctr for Special Immunology
🇺🇸Fort Lauderdale, Florida, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
🇺🇸Winston-Salem, North Carolina, United States
N Texas Ctr for AIDS & Clin Rsch
🇺🇸Dallas, Texas, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Saint Michael's Med Ctr
🇺🇸Newark, New Jersey, United States
Kaiser Permanente Med Ctr
🇺🇸Los Angeles, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
UCD Med Ctr
🇺🇸Sacramento, California, United States
Kaiser Foundation Hosp
🇺🇸Harbor City, California, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Sunset Park Health Ctr - Lutheran Med Ctr
🇺🇸Brooklyn, New York, United States
Davies Med Ctr
🇺🇸San Francisco, California, United States
Mount Zion Med Ctr
🇺🇸San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
Med Service
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Comprehensive Clinic / Dr Robert Schwartz
🇺🇸Fort Myers, Florida, United States
Albany Med College / AIDS Treatment Ctr
🇺🇸Albany, New York, United States