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
2 other identifiers
interventional
20
1 country
5
Brief Summary
To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
LAC and USC Med Ctr / School of Medicine
Los Angeles, California, 90033, United States
Univ of California / UCI Med Ctr
Orange, California, 92868, United States
UCSD Treatment Ctr
San Diego, California, 92103, United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699, United States
Harbor - UCLA Med Ctr - Box 449
Torrance, California, 90509, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-05