A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
• •Known or suspected hypersensitivity to benzodiazepines.
• •Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
• •Ongoing diarrhea (\> two liquid stools per day).
• •Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
• •Alteration of mental status that may interfere with study compliance.
• •Concurrent Medication:
• •Excluded:
• •AZT, ddI, or ddC.
• •Experimental antiretrovirals.
• •Biologic response modifiers or immunomodulating agents (e.g., interferon).
• •Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
• •Ganciclovir.
• •Foscarnet.
• •H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
• •Omeprazole.
• •Benzodiazepines.
• •Any other investigational compound.
• •Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
• •Cytotoxic chemotherapy (systemic and local).
• •Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
• •Paromomycin sulfate.
• •Chronic suppressive therapy for CMV and/or MAI.
• •Patients with the following prior condition are excluded:
• •History of serious adverse reactions to benzodiazepines.
• •Prior Medication:
• •Excluded:
• •Interferons or immune modulators within 4 weeks prior to study entry.
• •Prior systemic cytotoxic chemotherapy (patients with CD4 counts \>= 200 cells/mm3 only).
• •Benzodiazepines within 14 days prior to study entry.
• •Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
• •Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational drugs within 14 days prior to study entry.
• •Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.