A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma
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To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
No active opportunistic infection. NOTE:
Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
Life expectancy of at least 24 weeks.
Stable weight (+/- 2 kg) by 28 days prior to study entry.
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.
AZT, ddI, or ddC.
Biologic response modifiers or immunomodulating agents (e.g., interferon).
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
DNA Virus Infections
Neoplasms, Vascular Tissue