A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

June 23, 2005 updated by: Celgene Corporation
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

Study Type

Interventional

Enrollment

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • Marin County Specialty Clinic
      • Redwood City, California, United States, 940631633
        • AIDS Community Research Consortium
      • San Diego, California, United States, 921038681
        • UCSD Med Ctr - Owen Clinic
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Med Ctr
      • Sherman Oaks, California, United States, 91403
        • Gottlieb Med Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative of South Florida
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City AIDS Research Consortium
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Med Ctr
    • New York
      • New York, New York, United States, 10021
        • Rockefeller Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Med College
    • Washington
      • Seattle, Washington, United States, 981225314
        • Advanced Research Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
  • Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).

Patients must have:

  • Documented HIV infection.
  • Wasting syndrome.
  • Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
  • No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
  • Life expectancy of at least 6 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Chronic diarrhea (five or more unformed stools per day).
  • Peripheral neuropathy of grade 2 or worse.
  • Requirement for tube feeding or intravenous feeding.
  • Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
  • Inability to ingest at least a maintenance diet based on present weight.
  • Any condition that precludes study participation.
  • Not under the care of a primary physician.

Concurrent Medication:

Excluded:

  • Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).

Concurrent Treatment:

Excluded:

  • Radiotherapy.

Patients with the following prior conditions are excluded:

  • Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.
  • Prior intolerance to thalidomide.

Prior Medication:

Excluded:

  • ddC within 1 month prior to study entry.
  • Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
  • Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.

Prior Treatment:

Excluded:

  • Radiotherapy within 6 weeks prior to study entry.

Required ONLY IF patient is on antiretroviral therapy:

  • Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230A
  • W-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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