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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002157

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: December 1998

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Official Title ^ICMJE	Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
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.
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections HIV Wasting Syndrome
Intervention ^ICMJE	Drug: Thalidomide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002157
Other Study ID Numbers ^ICMJE	230B, W-002
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1998
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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