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
  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: 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:


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
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, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cachexia
HIV Infections
HIV Wasting Syndrome
Syndrome
Wasting Syndrome
Body Weight
Body Weight Changes
Disease
Emaciation
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Nutrition Disorders
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases
Weight Loss
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 30, 2014