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)
NCT ID: NCT00002079
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Butyldeoxynojirimycin
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* Documented HIV infection.
* CD4 cell count 200 - 500 cells/mm3.
* Prior therapy with 12 - 48 weeks of AZT.
Exclusion Criteria
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:
* History of cataracts or known increased risk of cataract formation.
* Known hypersensitivity to SC-48334 or AZT or related compounds.
* History of lactose intolerance.
Prior Medication:
Excluded:
* Prior SC-48334.
* Cancer chemotherapy within 6 months prior to study entry.
* Treatment with any investigational drug or any drug with anti-HIV activity, other than AZT, within 30 days prior to study entry.
Prior Treatment:
Excluded:
Whole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.
18 Years
ALL
No
Sponsors
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G D Searle
INDUSTRY
Locations
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Dr Marcus Conant
San Francisco, California, United States
Shared Med Research Foundation
Tarzana, California, United States
Stratogen of South Florida
Miami Beach, Florida, United States
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, United States
West Paces Clinical Research Incoporated
Atlanta, Georgia, United States
Dr Samuel W Golden
Pittsburgh, Pennsylvania, United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, United States
Dr Daniel Barbero
Fort Worth, Texas, United States
Park Plaza Hosp
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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NS8-91-02-009
Identifier Type: -
Identifier Source: secondary_id
057B
Identifier Type: -
Identifier Source: org_study_id