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
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To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Nelfinavir mesylate |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
Official Title: | 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 |
Estimated Enrollment: | 20 |
This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, California | |
LAC and USC Med Ctr / School of Medicine | |
Los Angeles, California, United States, 90033 | |
Univ of California / UCI Med Ctr | |
Orange, California, United States, 92868 | |
UCSD Treatment Ctr | |
San Diego, California, United States, 92103 | |
Santa Clara Valley Med Ctr | |
San Jose, California, United States, 951282699 | |
Harbor - UCLA Med Ctr - Box 449 | |
Torrance, California, United States, 90509 |
No publications provided
ClinicalTrials.gov Identifier: | NCT00002185 History of Changes |
Other Study ID Numbers: | 259F, AG1343-513 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms AIDS-Related Opportunistic Infections Sarcoma, Kaposi Drug Therapy, Combination |
HIV Protease Inhibitors Mucous Membrane Nelfinavir Anti-HIV Agents |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue HIV Protease Inhibitors Nelfinavir Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2013