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

Phase 2

Completed

• Conditions: HIV Infections; Stomatitis, Aphthous

• Registration Number: NCT00000790
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Completion: 1998-10
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (40)

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Univ of Southern California / LA County USC Med Ctr; 🇺🇸 Los Angeles, California, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Harbor UCLA Med Ctr; 🇺🇸 Torrance, California, United States

Univ of Colorado Health Sciences Ctr; 🇺🇸 Denver, Colorado, United States

Howard Univ; 🇺🇸 Washington, District of Columbia, United States

Univ of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Queens Med Ctr; 🇺🇸 Honolulu, Hawaii, United States

Univ of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

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