Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
- Conditions
- HIV InfectionsStomatitis, Aphthous
- Registration Number
- NCT00000790
- Brief Summary
PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment.
SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women.
Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
- Detailed Description
Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
Patients are randomized to receive 4 weeks of either thalidomide or placebo orally, administered once daily. Patients are followed weekly. Complete responders after 4 weeks of acute treatment enter a 24-week maintenance phase. A pharmacokinetic substudy will be included.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Meharry Med College
🇺🇸Nashville, Tennessee, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Illinois Masonic Med Ctr
🇺🇸Chicago, Illinois, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
North Central Bronx Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico