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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | November 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Effect of therapy on tumor pathogenesis as measured by vascular endothelial growth factor and Kaposi's sarcoma associated herpes virus levels at 3 months [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Effect of therapy on tumor pathogenesis as measured by vascular endothelial growth factor and Kaposi's sarcoma associated herpes virus levels at 3 months | ||||
| Change History | Complete list of historical versions of study NCT00020319 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Response based on tumor measurements every 3 months [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Response based on tumor measurements every 3 months | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Antiviral Therapy in Treating Patients Who Have or Are at Risk of Developing Kaposi's Sarcoma Related to HIV | ||||
| Official Title ICMJE | A Study of the Effects of Potent Anti-HIV Therapy on Parameters Hypothesized to be Related to the Pathogenesis of Kaposi's Sarcoma (KS) in HIV-Infected Individuals | ||||
| Brief Summary | RATIONALE: Herpesvirus is found in many Kaposi's sarcoma lesions. Antiviral drugs act against many types of herpes viruses and may be an effective treatment for Kaposi's sarcoma. PURPOSE: Phase II trial to study the effectiveness of combining antiviral drugs in treating patients with HIV who have or are at risk of developing Kaposi's sarcoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to disease status (diagnosis of KS vs KS-associated herpes virus positive but without diagnosis of KS). Each patient receives an individualized regimen comprising standard antiretroviral drugs. Antiretroviral therapy continues in the absence of progression of KS requiring chemotherapy or other specific therapy, development of another malignancy requiring chemotherapy or immunotherapy, or inability to maintain HIV RNA levels below 15,000 copies/mL on at least 2 sequential evaluations even when the therapeutic changes to optimize antiretroviral agents have been exhausted. PROJECTED ACCRUAL: A total of 24 patients (9 with KS and 15 at risk for developing KS) will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Sarcoma | ||||
| Intervention ICMJE | Procedure: antiviral therapy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020319 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068289, NCI-00-C-0193 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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