Inclusion Criteria
Patients must have:
- Serum HIV antibody positive by ELISA.
- KS documented by biopsy (repeat biopsy is not required for entry if KS has been previously confirmed histologically and the histopathology report has been reviewed).
- A minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Concurrent, serious, uncontrolled infection including, but not limited to:
- Mycobacterium avium intracellulare or other mycobacterium infection; Pneumocystis carinii pneumonia; CMV retinitis or colitis; Toxoplasma brain abscess; Cryptococcal meningitis.
- Serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
- Known allergy or sensitivity to retinoid class drugs.
Concurrent Medication:
Excluded:
- Local or topical therapy such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any KS indicator lesion.
- Systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy.
- Systemic use of retinoid class drugs, beta-carotene compounds, or Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) for any indication.
- Human chorionic gonadotropin.
Concurrent Treatment:
Excluded:
Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator lesion.
Prior Medication:
Excluded:
- Systemic treatment of KS within 30 days of study entry.
- Systemic treatment with either Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) or other retinoid class drugs for any indication within 30 days of study entry.
- Previous local or topical therapy of any KS indicator lesion such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry.
Prior Treatment:
Excluded:
- Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.