HIV Infections
Conditions
Keywords
Zidovudine, 1-Deoxynojirimycin
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.
Interventions
DRUGZidovudine
Sponsors
G D Searle
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed