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NCT00001524 · ClinicalTrials.gov registry record · Phase 2
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
A Phase 2 study of HIV Infection and Acquired Immunodeficiency Syndrome, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT00001524: Completed Phase 2 study of HIV Infection and Acquired Immunodeficiency Syndrome, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00001524 is a Phase 2 study of HIV Infection and Acquired Immunodeficiency Syndrome that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 110 participants, below the 241-participant average among 73 other HIV Infection trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001524, a Phase 2 study of HIV Infection and Acquired Immunodeficiency Syndrome, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
Conditions Studied
Interventions
- DRUG Thalidomide
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 1996-06 |
| Est. Completion | 2004-12 |
| Phase | Phase 2 |
What the finished NCT00001524 record still lists
NCT00001524 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 241-participant average among 73 other HIV Infection trials with a reported enrollment target (54% lower).
The record links to 3 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Thalidomide is the first listed.
NCT00001524 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001524 about?
NCT00001524 is a clinical study titled "Thalidomide to Treat Oral Lesions in HIV-Infected Patients". This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve dama...
What is the current status of trial NCT00001524?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 1996-06. Estimated completion is 2004-12.
What conditions does trial NCT00001524 study?
This clinical trial studies the following conditions: HIV Infection, Acquired Immunodeficiency Syndrome, Burning Mouth Syndrome.
What interventions are being tested in trial NCT00001524?
The interventions under investigation include: Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00001524?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001524 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001524's enrollment target sits among peer trials
110 24th of 73 higher than 50 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
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