Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
- Conditions
- HIV Infections
- Registration Number
- NCT00002079
- Lead Sponsor
- G D Searle
- Brief Summary
To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.
- 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)
West Paces Clinical Research Incoporated
🇺🇸Atlanta, Georgia, United States
Stratogen of South Florida
🇺🇸Miami Beach, Florida, United States
Dr Daniel Barbero
🇺🇸Fort Worth, Texas, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
🇺🇸Tampa, Florida, United States
Shared Med Research Foundation
🇺🇸Tarzana, California, United States
Dr Marcus Conant
🇺🇸San Francisco, California, United States
Dallas Veterans Administration Med Ctr
🇺🇸Dallas, Texas, United States
Park Plaza Hosp
🇺🇸Houston, Texas, United States
Dr Samuel W Golden
🇺🇸Pittsburgh, Pennsylvania, United States