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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: | Treatment, Double-Blind, Safety Study |
| 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 | |
| UCSD Med Ctr - Owen Clinic | |
| San Diego, California, United States, 921038681 | |
| Marin County Specialty Clinic | |
| Greenbrae, California, United States, 94904 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 940631633 | |
| 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
| Study ID Numbers: | 230A, W-001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002127 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome Cachexia Thalidomide |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Thalidomide Antineoplastic Agents HIV Wasting Syndrome Physiological Effects of Drugs Infection Body Weight Anti-Bacterial Agents Signs and Symptoms Pathologic Processes Therapeutic Uses Syndrome |
Weight Loss Body Weight Changes Nutrition Disorders Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections RNA Virus Infections Disease Metabolic Diseases Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions |