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Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome



Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

For Condition: HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): Celgene Corporation ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Celgene Corp
Warren,  New Jersey,  07059
United States
 


Additional Information:
Study ID Numbers:
  230B;  W-002
Study Start Date: 
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002157

Other Hiv Wasting Syndrome Studies:
1. A Study of L-735,524 in HIV-Positive Children and Adolescents

2. A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

3. A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

4. Effectiveness of AZT and Nevirapine in Preventing HIV Transmission from Ugandan Mothers to Their Newborns

5. The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children with AIDS

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