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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002445
Other study ID # 306A
Secondary ID KS-20898-01AMC-0
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date June 2001
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.


Other known NCT identifiers
  • NCT00003879

Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
IM862


Locations

Country Name City State
Australia St Vincent's Hosp / Dept of Haematology Darlinghurst
Australia Alfred Hosp Prahan
Australia Prince of Wales Hosp Randwick
Australia Taylors Square Clinic Sydney
Belgium Inst of Tropical Medicine Antwerpe
Belgium CHU Saint Pierre Brussels
Canada Montreal Gen Hosp / Div of Clin Immuno and Allergy Montreal Quebec
Canada Ottawa General Hospital Ottawa Ontario
Canada Sunnybrook Health Science Centre Toronto Ontario
Canada Toronto Gen Hosp Toronto Ontario
Canada BC Cancer Agency Vancouver British Columbia
United States Grady Mem Hosp Atlanta Georgia
United States Johns Hopkins Oncology Baltimore Maryland
United States Beth Israel Med Ctr Boston Massachusetts
United States Boston Med Ctr Boston Massachusetts
United States Massachusetts Gen Hosp Boston Massachusetts
United States Albert Einstein Comprehensive Ctr Bronx New York
United States Northwestern Univ Chicago Illinois
United States Case Western Reserve Univ Cleveland Ohio
United States Ohio State Univ Columbus Ohio
United States Infectious Disease of Indiana Indianapolis Indiana
United States Cytran Inc Kirkland Washington
United States AIDS Healthcare Foundation Los Angeles California
United States LAGLC Los Angeles California
United States Tower ID Med Associates Los Angeles California
United States UCLA Care Ctr Los Angeles California
United States USC School of Medicine / Norris Cancer Hosp Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Vanderbilt Cancer Ctr Nashville Tennessee
United States Columbia-Presbyterian Hosp New York New York
United States Mem Sloan - Kettering Cancer Ctr New York New York
United States New York Univ Med Ctr New York New York
United States St Vincents Hosp / Clinical Research Program New York New York
United States UMDNJ - New Jersey Med School Newark New Jersey
United States BioQuan Research Group North Miami Florida
United States Pennsylvania Oncology and Hematology Associates Philadelphia Pennsylvania
United States UCSD Med Ctr San Diego California
United States Conant Med Ctr San Francisco California
United States UCSF - San Francisco Gen Hosp San Francisco California
United States Univ of Washington / Harborview Med Ctr Seattle Washington
United States Virginia Mason Med Ctr Seattle Washington
United States Washington Univ School of Medicine St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Cytran

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada, 

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