Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
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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: | Masking: Open Label Primary Purpose: Treatment |
| 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:
- Antiretroviral therapy.
- Prophylaxis or treatment for opportunistic infection.
Patients must have:
HIV-associated wasting.
Prior Medication:
Allowed:
- Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002157 History of Changes |
| Other Study ID Numbers: | 230B, W-002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Acquired Immunodeficiency Syndrome Cachexia Thalidomide |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Wasting Syndrome 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 |
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 Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on March 07, 2013
