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

This study has been completed.

Sponsored by: Celgene Corporation
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002157
  Purpose

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 Intervention
HIV Infections
HIV Wasting Syndrome
Drug: Thalidomide

MedlinePlus related topics:   AIDS   

Drug Information available for:   Thalidomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002157

Locations
United States, New Jersey
Celgene Corp    
      Warren, New Jersey, United States, 07059

Sponsors and Collaborators
Celgene Corporation
  More Information


Study ID Numbers:   230B, W-002
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002157
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Thalidomide
HIV Wasting Syndrome
Acquired Immunodeficiency Syndrome
Cachexia
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Nutrition Disorders
Wasting Syndrome
Metabolic disorder
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Infection
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on December 03, 2008




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