Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
Public ClinicalTrials.gov record NCT00000790. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000790
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 164 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Oct 1998 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1998
United States locations
- U.S. sites
- 39
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | — |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco | California | 941102859 | — |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Howard Univ | Washington D.C. | District of Columbia | 20059 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Queens Med Ctr | Honolulu | Hawaii | 96816 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | — |
| Louis A Weiss Memorial Hosp | Chicago | Illinois | 60640 | — |
| Illinois Masonic Med Ctr | Chicago | Illinois | 606575147 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| Beth Israel Med Ctr | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Mount Sinai Med Ctr / Pediatrics | New York | New York | 10029 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | — |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | — |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | — |
| Montefiore Med Ctr / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| North Central Bronx Hosp / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| Bronx Veterans Administration / Mount Sinai Hosp | The Bronx | New York | 10468 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 170330850 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Meharry Med College | Nashville | Tennessee | 37203 | — |
| Univ of Washington | Seattle | Washington | 981224304 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000790, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2021 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000790 live on ClinicalTrials.gov.