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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 Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants typically obtain the most effective healthcare available for their 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 condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): Celgene Corporation ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 75
Location and Contact Information:
Advanced Research Management
Seattle, Washington, 981225314
United States
Rockefeller Univ
New York City, New York, 10021
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
United States
AIDS Community Research Consortium
Redwood City, California, 940631633
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107
United States
Gottlieb Med Group
Sherman Oaks, California, 91403
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Marin County Specialty Clinic
Greenbrae, California, 94904
United States
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
United States
Additional Information:
Study ID Numbers: 230A; W-001
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002127
Other Hiv Wasting Syndrome Studies:
1. A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
2. 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
3. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
4. Growth Hormone in the Treatment of HIV-Associated Wasting
5. The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Related Studies:
Other HIV Wasting Syndrome Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
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
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