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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002127 |
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 II |
| 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 |
| Estimated Enrollment: | 75 |
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 |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Required ONLY IF patient is on antiretroviral therapy:
Contacts and 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 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| 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 | |
More Information
| 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 |
|
Acquired Immunodeficiency Syndrome Cachexia Thalidomide |
|
HIV Infections Acquired Immunodeficiency Syndrome Wasting Syndrome Weight Loss HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Metabolic Diseases |
Nutrition Disorders Body Weight Changes Body Weight Signs and Symptoms Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents |