A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3

Inclusion Criteria

Patients must have:

• HIV-positivity.
• Diagnosed KS proven by biopsy.
• NOTE:
• Patients must not opt for immediate topical, systemic or radiation treatment.
• At least 4 cutaneous lesions not treated within the previous 4 weeks.
• Life expectancy > 6 months.
• Signed, informed consent from parent or legal guardian for those patients < 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

• Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies.
• Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS.
• Clinically significant malabsorption syndrome.
• Renal insufficiency.

Patients with any of the following prior conditions are excluded:

Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline.

1. Immediate topical or systemic treatment for KS lesions.

• Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently.

Immediate radiation treatment.

1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry.

• History of > 2 weeks of prior therapy with Indinavir or Ritonavir.
• Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry.

Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.