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A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002188
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ligand Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.

Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Interventional
Phase 2
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Alitretinoin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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Inclusion Criteria

Patients must have:

  • HIV positive status and histologic confirmation of KS.
  • CD4 count > 200 mm3 (required of one-half of patients).
  • Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
  • Acceptable organ system function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.

Prior Medication:

Excluded:

  • Systemic therapy for KS within 30 days.
  • Local or topical therapy for KS indicative lesions within 60 days.
  • Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.

Required:

Approved antiretroviral therapy.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00002188
271A
L1057-28
96ACR-LIG2
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Anderson Clinical Research
Ligand Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
August 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP