A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms and conditions are excluded:
• •Known or suspected hypersensitivity to benzodiazepines.
• •Presence of any malignancy other than basal cell carcinoma or limited cutaneous Kaposi's sarcoma (defined as no more than five lesions with no mucosal involvement).
• •Ongoing diarrhea, defined as more than 2 liquid stools per day.
• •History, physical exam, or laboratory results consistent with a subclinical AIDS-defining opportunistic infection.
• •Grade 2 or greater signs and symptoms of AIDS Dementia Complex.
• •Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease.
• •Concurrent Medication:
• •Excluded:
• •Chronic suppressive therapy for CMV, MAI, toxoplasmosis, cryptococcosis, cryptosporidiosis, coccidioidomycosis, and histoplasmosis.
• •ddC, ddI, AZT (except for control groups) or other experimental antiretrovirals or immunomodulating agents.
• •Other medications excluded from the study.
• •Patients with the following prior conditions are excluded:
• •History of serious adverse reactions to benzodiazepines.
• •History of intolerance to AZT at 600 mg/day or less or ddI at 400 mg/day or less.
• •History of unexplained fever, defined as a temperature of 38.5 deg C or greater with or without night sweats for more than 7 of the past 28 days.
• •Prior Medication:
• •Excluded:
• •Benzodiazepines within 14 days prior to study entry.
• •Active drug or alcohol abuse that would interfere with study compliance.