Completed
Thalidomide for Reducing Weight Loss in HIV Wasting Syndrome
What is being tested
Thalidomide
Drug
Who is being recruted
Blood-Borne Infections+25
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+24 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
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 either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.
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.Design Details
75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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
8 inclusion criteria required to participate
Stable regimen of AZT or ddI for at least 1 month prior to study entry. (ONLY IF patient is on antiretroviral therapy)
No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
Life expectancy of at least 6 weeks.
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16 exclusion criteria prevent from participating
Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).
Radiotherapy.
ddC within 1 month prior to study entry.
Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
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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 13 locations
Marin County Specialty Clinic
Greenbrae, United StatesOpen Marin County Specialty Clinic in Google MapsAIDS Community Research Consortium
Redwood City, United StatesUCSD Med Ctr - Owen Clinic
San Diego, United StatesSan Francisco Gen Hosp
San Francisco, United StatesCompleted13 Study Centers