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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002445
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 2001
History of Changes
  Purpose

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.


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
 Drug: IM862
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 200
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002445

  Show 42 Study Locations
Sponsors and Collaborators
Cytran
Investigators
Study Chair: Parkash Gill
Study Chair: David Scadden
Study Chair: Ariela Noy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002445     History of Changes
Obsolete Identifiers: NCT00003879
Other Study ID Numbers: 306A, KS-20898-01, AMC-013
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Placebos
Sarcoma, Kaposi
 Antineoplastic Agents
Treatment Outcome
Quality of Life

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013