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)
2 other identifiers
interventional
N/A
1 country
9
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.
Trial Health
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9 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV infection.
- CD4 cell count 200 - 500 cells/mm3.
- Prior therapy with 12 - 48 weeks of AZT.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant diarrhea without definable cause (\> 3 liquid stools per day for more than 7 days within 6 months prior to study entry).
- Diarrhea, as above, with known non-HIV-related cause occurring within 1 month prior to study entry.
- Symptoms meeting CDC criteria for AIDS classification.
- Fever as a constitutional sign of HIV disease (\> 38.5 degrees C persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry).
- Malignancies, other than basal cell carcinoma and Kaposi's sarcoma (provided patient has fewer than 10 Kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment).
- Significant organ dysfunction.
- Known hypersensitivity to SC-48334 or AZT or related compounds.
- Concurrent Medication:
- Excluded:
- Any investigational drug other than SC-48334.
- Any anti-HIV drug other than AZT.
- Cancer chemotherapy.
- Patients with the following prior conditions are excluded:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- G D Searlelead
Study Sites (9)
Dr Marcus Conant
San Francisco, California, 94115, United States
Shared Med Research Foundation
Tarzana, California, 91356, United States
Stratogen of South Florida
Miami Beach, Florida, 33140, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, 33614, United States
West Paces Clinical Research Incoporated
Atlanta, Georgia, 30327, United States
Dr Samuel W Golden
Pittsburgh, Pennsylvania, 15218, United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216, United States
Dr Daniel Barbero
Fort Worth, Texas, 76104, United States
Park Plaza Hosp
Houston, Texas, 77004, United States
Related Publications (1)
Fischl MA, Resnick L, Coombs R, Kremer AB, Pottage JC Jr, Fass RJ, Fife KH, Powderly WG, Collier AC, Aspinall RL, et al. The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3. J Acquir Immune Defic Syndr (1988). 1994 Feb;7(2):139-47.
PMID: 7905523BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1993-03