HIV InfectionsPhase 2NCT00000790
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
A Phase 2 study testing Thalidomide in people with HIV Infections and Stomatitis, Aphthous, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Stomatitis, Aphthous
- What is being tested?
- Thalidomide
- How many people
- 164 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Start not givento Oct 1998
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States39 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
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
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
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
Case Western Reserve Univ
Cleveland, Ohio, 44106
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Univ of Miami School of Medicine
Miami, Florida, 331361013
Meharry Med College
Nashville, Tennessee, 37203
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
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
Univ of Washington
Seattle, Washington, 981224304
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
Harbor UCLA Med Ctr
Torrance, California, 90502
Howard Univ
Washington D.C., District of Columbia, 20059
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Stomatitis, Aphthous
- Being tested
- Thalidomide
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thalidomide, Stomatitis, Aphthous
- Medical subject headings
- HIV Infections, Stomatitis, Aphthous, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 164 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Andrulis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Jacobson JM, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000790
- Sponsor's protocol ID
- ACTG 251
- Other IDs
- 11228
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Jacobson JM, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Wu AW, Hooton TM, Sha BE, Shikuma CM, MacPhail LA, Simpson DM, Trapnell CB, Basgoz N. Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group. J Infect Dis. 1999 Jul;180(1):61-7. doi: 10.1086/314834.
PubMed 10353862Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.
PubMed 9154767Gilden D. Thalidomide and aphthous ulcers. GMHC Treat Issues. 1995 Nov;9(11):12.
PubMed 11362988Jacobson JM, Greenspan JS, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Pulvirenti JJ, Hooton TM, Shikuma C. Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. J Infect Dis. 2001 Jan 15;183(2):343-346. doi: 10.1086/317928. Epub 2000 Dec 15.
PubMed 11120935Aweeka F, Trapnell C, Chernoff M, Jayewardene A, Spritzler J, Bellibas SE, Lizak P, Jacobson J. Pharmacokinetics and pharmacodynamics of thalidomide in HIV patients treated for oral aphthous ulcers: ACTG protocol 251. AIDS Clinical Trials Group. J Clin Pharmacol. 2001 Oct;41(10):1091-7. doi: 10.1177/00912700122012698.
PubMed 11583477
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00000790
- Acronym / sponsor ID
- ACTG 251
- Conditions
- HIV Infections, Stomatitis, Aphthous
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thalidomide, Stomatitis, Aphthous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Andrulis Pharmaceuticals
- Study completion
- Oct 1998 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (29 listed)
- Known allergy to thalidomide.
- Grade 2 or worse bilateral peripheral neuropathy.
- Toxicity other than somnolence in acute phase that required discontinuation of drug.
- Acute therapy for opportunistic infection.
- ddC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 10353862Jacobson JM, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Wu AW, Hooton TM, Sha BE, Shikuma CM, MacPhail LA, Simpson DM, Trapnell CB, Basgoz N. Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group. J Infect Dis. 1999 Jul;180(1):61-7. doi: 10.1086/314834.
- Background: PubMed 9154767Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.
- Background: PubMed 11362988Gilden D. Thalidomide and aphthous ulcers. GMHC Treat Issues. 1995 Nov;9(11):12.
- Background: PubMed 11120935Jacobson JM, Greenspan JS, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Pulvirenti JJ, Hooton TM, Shikuma C. Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. J Infect Dis. 2001 Jan 15;183(2):343-346. doi: 10.1086/317928. Epub 2000 Dec 15.
- Background: PubMed 11583477Aweeka F, Trapnell C, Chernoff M, Jayewardene A, Spritzler J, Bellibas SE, Lizak P, Jacobson J. Pharmacokinetics and pharmacodynamics of thalidomide in HIV patients treated for oral aphthous ulcers: ACTG protocol 251. AIDS Clinical Trials Group. J Clin Pharmacol. 2001 Oct;41(10):1091-7. doi: 10.1177/00912700122012698.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobson JM study chair
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with HIV Infections and Stomatitis, Aphthous, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000790, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.