Completed

Thalidomide for Reducing Weight Loss in HIV Wasting Syndrome

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What is being tested

Thalidomide

Drug
Who is being recruted

Blood-Borne Infections+25

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

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
Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC)

Documented HIV infection

Life expectancy of at least 6 weeks

Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry

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16 exclusion criteria prevent from participating
Active drug abuse within 3 months prior to study entry

Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry

Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry

Any condition that precludes study participation

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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 Maps

AIDS Community Research Consortium

Redwood City, United States

UCSD Med Ctr - Owen Clinic

San Diego, United States

San Francisco Gen Hosp

San Francisco, United States
Completed13 Study Centers