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Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection



Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection

For Condition: HIV Infections,Stomatitis, Aphthous
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Andrulis Pharmaceuticals
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Anti-HIV therapy provided therapy has remained constant in the 4 weeks prior to study entry. - Narcotic analgesia after the first week of treatment ONLY IF the patient is not experiencing somnolence. Patients must have: - Documented HIV infection or AIDS. - Biopsy-confirmed aphthous ulceration of the mouth or esophagus lasting at least 2 weeks. - Negative culture of ulcer for Herpes simplex. - En face diameter of >= 5 mm for largest aphthous ulcer. - Life expectancy of at least 3 months. NOTE: - This study is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known allergy to thalidomide. - Grade 2 or worse bilateral peripheral neuropathy. EXCLUDED FOR MAINTENANCE PHASE: - Toxicity other than somnolence in acute phase that required discontinuation of drug. Concurrent Medication: Excluded: - Acute therapy for opportunistic infection. - ddC. - Pentoxifylline. - Methotrexate, trimetrexate, antineoplastic alkylating agents. - Other putative immunomodulators. - CNS depressants and/or medications with sedative or hypnotic effect. - Systemic and/or oral topical corticosteroids. - Systemic chemotherapy for Kaposi's sarcoma or other malignancies. - Compounded antibacterial mouthwashes containing anti-infective agents (such as doxycycline, minocycline, tetracycline, or nystatin). Concurrent Treatment: Excluded: - Radiation to head and/or neck. Patients with the following prior conditions are excluded: - History of grade 2 or worse bilateral peripheral neuropathy. - Change in anti-HIV therapy within 4 weeks prior to study entry. - Prior enrollment in ACTG 251 or prior treatment of aphthous ulcers with thalidomide. Prior Medication: Excluded: - Systemic and/or oral topical corticosteroids within 1 week prior to first set of bloods drawn. - Other putative immunomodulators within 2 weeks prior to study entry. - Prior thalidomide for aphthous ulcers.
Total Enrollment: 164

Location and Contact Information:

Overall Study Official:
JacobsonJM,  Study Chair, 

SUNY / State Univ of New York
Syracuse,  New York,  13210
United States
 

San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco,  California,  94115
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Bronx Veterans Administration / Mount Sinai Hosp
Bronx,  New York,  10468
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Meharry Med College
Nashville,  Tennessee,  37203
United States
 

Milton S Hershey Med Ctr
Hershey,  Pennsylvania,  170330850
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 

Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

North Central Bronx Hosp / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Howard Univ
Washington D.C.,  District of Columbia,  20059
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

Illinois Masonic Med Ctr
Chicago,  Illinois,  606575147
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Univ of Puerto Rico
San Juan,  ,  009365067
Puerto Rico
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 


Additional Information:
Study ID Numbers:
  ACTG 251; 
Study Start Date: 
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000790

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