Completed
Thalidomide Dosing in Adults with HIV Wasting Syndrome
What is being tested
Thalidomide
Drug
Who is being recruted
Blood-Borne Infections+25
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorCelgene Corporation
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorCelgene Corporation
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBody WeightBody Weight ChangesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSlow Virus DiseasesPathological Conditions, Signs and SymptomsThinnessVirus DiseasesSexually Transmitted Diseases, ViralWeight LossLentivirus InfectionsWasting SyndromeAcquired Immunodeficiency SyndromeCachexiaHIV InfectionsHIV Wasting Syndrome
Criteria
4 inclusion criteria required to participate
Allowed: Antiretroviral therapy
Allowed: Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study
Allowed: Prophylaxis or treatment for opportunistic infection
Patients must have HIV-associated wasting
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center