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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002445 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
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Scientific title:
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A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma |
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Date of first enrolment:
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October 1995 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002445 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Belgium
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Canada
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United States
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Contacts
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Name:
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Ariela Noy |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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David Scadden |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Parkash Gill |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have AIDS-related Kaposi's sarcoma.
- Have at least 5 skin or mouth sores that do not require chemotherapy.
- Have been taking anti-HIV drugs for at least 8 weeks before study entry with no
changes in the regimen.
- Are at least 18 years old.
- Agree to practice effective methods of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have an AIDS-related opportunistic infection (except for genital herpes) within 2
weeks of study entry.
- Have had another type of cancer within the past 2 years (except for certain types of
skin cancer, cervical cancer, or anal cancer).
- Have a severe chest cold.
- Have certain other serious medical conditions.
- Have received certain medications, including chemotherapy, within the past 4 weeks.
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Sarcoma, Kaposi
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Intervention(s)
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Drug: IM862
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Secondary ID(s)
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306A
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AMC-013
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KS-20898-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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