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

This study has been completed.
Sponsor:
Collaborator:
Andrulis Pharmaceuticals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000790
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Stomatitis, Aphthous
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 164
Study Completion Date: October 1998
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000790

  Show 40 Study Locations
Sponsors and Collaborators
Andrulis Pharmaceuticals
Investigators
Study Chair: Jacobson JM
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000790     History of Changes
Other Study ID Numbers: ACTG 251, 11228
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Thalidomide
Stomatitis, Aphthous

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Stomatitis
Stomatitis, Aphthous
Viremia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014