A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
- Conditions
- HIV Infections
- Registration Number
- NCT00000791
- Brief Summary
To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens.
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
- Detailed Description
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
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 (22)
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
USC CRS
🇺🇸Los Angeles, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
Wake County Health and Human Services CRS
🇺🇸Raleigh, North Carolina, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States