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
NCT ID: NCT00002127
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
75 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thalidomide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene Corporation
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marin County Specialty Clinic
Greenbrae, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
UCSD Med Ctr - Owen Clinic
San Diego, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
Gottlieb Med Group
Sherman Oaks, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Community Research Initiative of South Florida
Coral Gables, Florida, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
Saint Michael's Med Ctr
Newark, New Jersey, United States
Rockefeller Univ
New York, New York, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, United States
Advanced Research Management
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W-001
Identifier Type: -
Identifier Source: secondary_id
230A
Identifier Type: -
Identifier Source: org_study_id