Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
G D Searle
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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:
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.
