Search / Trial NCT00002445

Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients

Launched by CYTRAN · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Aids Related Opportunistic Infections Placebos Sarcoma, Kaposi Antineoplastic Agents Treatment Outcome Quality Of Life

ClinConnect Summary

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 a...

Gender

ALL

Eligibility 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.
  • 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.

Trial Officials

Parkash Gill

Study Chair

David Scadden

Study Chair

Ariela Noy

Study Chair

About Cytran

Cytran is a leading clinical trial sponsor dedicated to advancing medical research and enhancing patient care through innovative trial management solutions. With a strong focus on operational excellence and regulatory compliance, Cytran collaborates with healthcare institutions and researchers to streamline the clinical trial process, ensuring efficient study design, execution, and data analysis. By leveraging cutting-edge technology and a team of experienced professionals, Cytran aims to accelerate the development of new therapies and improve outcomes for patients globally.

Locations

Miami, Florida, United States

Cleveland, Ohio, United States

Los Angeles, California, United States

San Francisco, California, United States

Brussels, , Belgium

New York, New York, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

Newark, New Jersey, United States

Toronto, Ontario, Canada

Toronto, Ontario, Canada

New York, New York, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

San Diego, California, United States

Montreal, Quebec, Canada

San Francisco, California, United States

Los Angeles, California, United States

Philadelphia, Pennsylvania, United States

Ottawa, Ontario, Canada

St. Louis, Missouri, United States

Seattle, Washington, United States

Seattle, Washington, United States

New York, New York, United States

Los Angeles, California, United States

Atlanta, Georgia, United States

Los Angeles, California, United States

North Miami, Florida, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Bronx, New York, United States

New York, New York, United States

Columbus, Ohio, United States

Nashville, Tennessee, United States

Kirkland, Washington, United States

Darlinghurst, , Australia

Prahan, , Australia

Randwick, , Australia

Sydney, , Australia

Antwerpe, , Belgium

Vancouver, British Columbia, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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