Back to resultsCompassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Primary Purpose
HIV Infections, HIV Wasting Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
Eligibility Criteria
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.
Sites / Locations
- Celgene Corp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002157
Brief Title
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Official Title
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Celgene Corporation
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome
Keywords
Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Celgene Corp
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
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