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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).

Key facts

Study ID

NCT00002185

Run by

Agouron Pharmaceuticals

People needed

20

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• 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.

Where it is running

• LAC and USC Med Ctr / School of Medicine — Los Angeles, California, United States
• Univ of California / UCI Med Ctr — Orange, California, United States
• UCSD Treatment Ctr — San Diego, California, United States
• Santa Clara Valley Med Ctr — San Jose, California, United States
• Harbor - UCLA Med Ctr - Box 449 — Torrance, California, United States

Full record on ClinicalTrials.gov

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