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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002127
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  Purpose

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.


Condition Intervention Phase
HIV Infections
HIV Wasting Syndrome
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 75
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00002127

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

Publications:
ClinicalTrials.gov Identifier: NCT00002127     History of Changes
Other Study ID Numbers: 230A, W-001
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
Weight Loss
Body Weight
Body Weight Changes
Disease
Emaciation
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Metabolic Diseases
Nutrition Disorders
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on November 24, 2014