Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Biological Availability, 1-Deoxynojirimycin
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Nystatin. Clotrimazole. Topical acyclovir. Concurrent Treatment: Allowed: Blood transfusions for = or > grade 3 hemoglobin toxicity. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: Clinical significant diarrhea (> 3 stools per day for > 7 days without definable cause). Active opportunistic infection, requiring ongoing therapy, at time of enrollment. Any malignancy besides Kaposi's sarcoma, basal cell carcinoma, or squamous cell carcinoma unless the squamous cell carcinoma requires ongoing therapy. Neurologic disease including dementia, peripheral neuropathy, myelopathy (CDC category IVb). Concurrent Medication: Excluded: Antimetabolites. Alkylating agents. Drugs with known hepatic or bone marrow toxicity. Patients with significant organ dysfunction will be excluded. Prior Medication: Excluded: Antimetabolites. Alkylating agents. Excluded within 30 days of study entry: Any investigational medication. Drugs with anti-HIV activity. Excluded within 90 days of study entry: Ribavirin treatment. Excluded within 6 months of study entry: Cancer chemotherapy. Prior Treatment: Excluded within 6 months of study entry: Radiation therapy. Patients must demonstrate the following clinical and laboratory findings: AIDS or advanced AIDS related complex (ARC), according to Centers for Disease Control (CDC) category IV, excluding neurologic disease in IVb. Ability to understand the terms of study participation. Current use of illicit drugs or abuse of alcohol.
Sites / Locations
- Univ of California / San Diego Treatment Ctr
- Stanford Univ School of Medicine
- Univ of Miami School of Medicine
- Rush Presbyterian - Saint Luke's Med Ctr
- Harvard (Massachusetts Gen Hosp)
- Julio Arroyo