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A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma Clinical research trials and A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma. A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma clinical trial. Participants typically obtain the most effective healthcare available for their A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma
A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Ligand Pharmaceuticals ,
Synopsis: The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS).
Details: This is a multicenter, open-label study to evaluate the safety and efficacy of Targretin capsules in patients with AIDS-related KS. NOTE: The daily dose may be reduced as necessary for toxicity management.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Serum HIV antibody positive by ELISA. - KS documented by biopsy (repeat biopsy is not required for entry if KS has been previously confirmed histologically and the histopathology report has been reviewed). - A minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Concurrent, serious, uncontrolled infection including, but not limited to: - Mycobacterium avium intracellulare or other mycobacterium infection; Pneumocystis carinii pneumonia; CMV retinitis or colitis; Toxoplasma brain abscess; Cryptococcal meningitis. - Serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. - Known allergy or sensitivity to retinoid class drugs. Concurrent Medication: Excluded: - Local or topical therapy such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any KS indicator lesion. - Systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy. - Systemic use of retinoid class drugs, beta-carotene compounds, or Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) for any indication. - Human chorionic gonadotropin. Concurrent Treatment: Excluded: Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator lesion. Prior Medication: Excluded: - Systemic treatment of KS within 30 days of study entry. - Systemic treatment with either Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) or other retinoid class drugs for any indication within 30 days of study entry. - Previous local or topical therapy of any KS indicator lesion such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry. Prior Treatment: Excluded: - Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.
Total Enrollment: 27
Location and Contact Information:
Desert Univ School of Medicine
Palm Springs, California, 92262
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 17033
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: 287A; L1069-21
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002212
Other Sarcoma, Kaposi Studies:
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2. Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
3. Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients
4. Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN alfa-2b), and Ribavirin (RBV) Treatment in Patients with Hepatitis C and HIV Coinfection
5. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
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A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma
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