| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | 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 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002157 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|
|
