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| Sponsored by: |
Celgene Corporation |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002157 |
Purpose
To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.
| Condition | Intervention |
|---|---|
|
HIV Infections HIV Wasting Syndrome |
Drug: Thalidomide |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome |
Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.
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:
HIV-associated wasting.
Prior Medication:
Allowed:
Contacts and Locations
More Information
| Study ID Numbers: | 230B, W-002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002157 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Acquired Immunodeficiency Syndrome Cachexia Thalidomide |
|
Sexually Transmitted Diseases, Viral Metabolic Diseases Immunologic Factors Thalidomide HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Cachexia Angiogenesis Inhibitors Immunosuppressive Agents |
Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents HIV Infections Sexually Transmitted Diseases Nutrition Disorders Wasting Syndrome Retroviridae Infections Metabolic Disorder |
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Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Thalidomide Immunologic Factors Antineoplastic Agents HIV Wasting Syndrome Physiological Effects of Drugs Infection Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Syndrome 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 Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases |