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


Phase 2
13 Years
N/A
Not Enrolling
Both
HIV Infections, Stomatitis, Aphthous

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Jacobson JM

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 251

NCT ID:

NCT00000790

Start Date:

Completion Date:

October 1998

Related Keywords:

  • HIV Infections
  • Stomatitis, Aphthous
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Thalidomide
  • Stomatitis, Aphthous
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Stomatitis
  • Stomatitis, Aphthous
  • Viremia

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Harbor UCLA Med CtrTorrance, California  90502
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Mount Sinai Med CtrNew York, New York  10029
SUNY / State Univ of New YorkSyracuse, New York  13210
Univ of North CarolinaChapel Hill, North Carolina  275997215
Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Univ of WashingtonSeattle, Washington  98105
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Cook County HospChicago, Illinois  60612
Montefiore Drug Treatment Ctr / Bronx Municipal HospBronx, New York  10461
Montefiore Family Health Ctr / Bronx Municipal HospBronx, New York  10461
Comprehensive Health Care Ctr / Bronx Municipal HospBronx, New York  10461
North Central Bronx Hosp / Bronx Municipal HospBronx, New York  10467
Beth Israel Med CtrNew York, New York  10003
Thomas Jefferson Univ HospPhiladelphia, Pennsylvania  191075098
Howard UnivWashington, District of Columbia  20059
Univ of HawaiiHonolulu, Hawaii  96816
Louis A Weiss Memorial HospChicago, Illinois  60640
Case Western Reserve UnivCleveland, Ohio  44106
Meharry Med CollegeNashville, Tennessee  37203
Queens Med CtrHonolulu, Hawaii  96816
Illinois Masonic Med CtrChicago, Illinois  606575147
Montefiore Adolescent AIDS Prog / Bronx Municipal HospBronx, New York  10461
Mount Sinai Med Ctr / PediatricsNew York, New York  10029