A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma
Patients must have:
- HIV seropositivity.
- Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and
- 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
- 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.
- Experimental antiretrovirals.
- Biologic response modifiers or immunomodulating agents (e.g., interferon).
- Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
- H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
- 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
- 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.
- Interferons or immune modulators within 4 weeks prior to study entry.
- Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3
- 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.