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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002445




Registration number
NCT00002445
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
24/06/2005

Titles & IDs
Public title
Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
Scientific title
A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma
Secondary ID [1] 0 0
KS-20898-01
Secondary ID [2] 0 0
306A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma, Kaposi 0 0
HIV Infections 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hosp / Dept of Haematology - Darlinghurst
Recruitment hospital [2] 0 0
Alfred Hosp - Prahan
Recruitment hospital [3] 0 0
Prince of Wales Hosp - Randwick
Recruitment hospital [4] 0 0
Taylors Square Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Prahan
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
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United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerpe
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cytran
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
Trial website
https://clinicaltrials.gov/study/NCT00002445
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Parkash Gill
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002445