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

Inclusion Criteria

Patients must have:

* HIV seropositivity.
* 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.

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.