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)

Study Overview
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Brief Summary
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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.

Official Title
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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
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HIV Infections

Intervention / Treatment
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* Drug: Butyldeoxynojirimycin
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count 200 - 500 cells/mm3. Prior therapy with 12 - 48 weeks of AZT. Exclusion Criteria 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Butyldeoxynojirimycin|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zidovudine, 1-Deoxynojirimycin