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

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ClinicalTrials.gov Identifier: NCT00002157
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Wasting Syndrome Drug: Thalidomide Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Thalidomide
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002157


Locations
United States, New Jersey
Celgene Corp
Warren, New Jersey, United States, 07059
Sponsors and Collaborators
Celgene Corporation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00002157     History of Changes
Other Study ID Numbers: 230B
W-002
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Cachexia
Thalidomide

Additional relevant MeSH terms:
Syndrome
HIV Infections
Cachexia
Wasting Syndrome
HIV Wasting Syndrome
Disease
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors