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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Thalidomide

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	230B, W-002
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002157 History of Changes
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
Immunologic Factors
Thalidomide
HIV Wasting Syndrome
Acquired Immunodeficiency Syndrome
Cachexia
Angiogenesis Inhibitors
Immunosuppressive Agents

Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
HIV Infections
Sexually Transmitted Diseases
Nutrition Disorders
Wasting Syndrome
Retroviridae Infections
Metabolic Disorder

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Thalidomide
Immunologic Factors
Antineoplastic Agents
HIV Wasting Syndrome
Physiological Effects of Drugs
Infection
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Nutrition Disorders
Growth Inhibitors

Angiogenesis Modulating Agents
Retroviridae Infections
RNA Virus Infections
Disease
Metabolic Diseases
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Angiogenesis Inhibitors
Immunosuppressive Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on July 02, 2009