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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

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:	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 NLM:

MedlinePlus related topics: HIV/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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


ClinicalTrials.gov Identifier:	NCT00002157 History of Changes
Other Study ID Numbers:	230B W-002
First Submitted:	November 2, 1999
First Posted:	August 31, 2001
Last Update Posted:	December 9, 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

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