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| Sponsored by: |
Agouron Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002185 |
Purpose
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| 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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
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.
Contacts and Locations| United States, California | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 951282699 | |
| Univ of California / UCI Med Ctr | |
| Orange, California, United States, 92868 | |
| UCSD Treatment Ctr | |
| San Diego, California, United States, 92103 | |
| LAC and USC Med Ctr / School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| Harbor - UCLA Med Ctr - Box 449 | |
| Torrance, California, United States, 90509 | |
More Information
| Study ID Numbers: | 259F, AG1343-513 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002185 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Skin Neoplasms AIDS-Related Opportunistic Infections Sarcoma, Kaposi Drug Therapy, Combination |
HIV Protease Inhibitors Mucous Membrane Nelfinavir Anti-HIV Agents |
|
Opportunistic Infections HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Skin Neoplasms Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Herpesviridae Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Anti-Retroviral Agents HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Nelfinavir Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Neoplasms, Connective and Soft Tissue Anti-Retroviral Agents Therapeutic Uses Neoplasms, Vascular Tissue Nelfinavir Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Neoplasms by Histologic Type |
Immune System Diseases Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Protease Inhibitors Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Sarcoma |