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Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002157
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.
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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Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.
Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.
Interventional
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Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • HIV Wasting Syndrome
Drug: Thalidomide
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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
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy.
  • Prophylaxis or treatment for opportunistic infection.

Patients must have:

HIV-associated wasting.

Prior Medication:

Allowed:

  • Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002157
230B
W-002
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Celgene Corporation
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NIH AIDS Clinical Trials Information Service
December 1998

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