Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
NCT ID: NCT00004276
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
1990-09-30
1999-06-30
Brief Summary
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II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.
III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.
Detailed Description
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Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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thalidomide
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment
Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis
At least 1 of the following signs and symptoms required:
* Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment
* Weight loss greater than 5 kg
* Pulmonary involvement in at least 1 lobe on x-ray
Night sweats on at least 2 occasions within 1 week prior to treatment
--Prior/Concurrent Therapy--
Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed
--Patient Characteristics--
* No neuropathy and not at risk for neuropathy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Rockefeller University
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Gilla Kaplan
Role: STUDY_CHAIR
Rockefeller University
References
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Haslett P, Tramontana J, Burroughs M, Hempstead M, Kaplan G. Adverse reactions to thalidomide in patients infected with human immunodeficiency virus. Clin Infect Dis. 1997 Jun;24(6):1223-7. doi: 10.1086/513665.
Tramontana JM, Utaipat U, Molloy A, Akarasewi P, Burroughs M, Makonkawkeyoon S, Johnson B, Klausner JD, Rom W, Kaplan G. Thalidomide treatment reduces tumor necrosis factor alpha production and enhances weight gain in patients with pulmonary tuberculosis. Mol Med. 1995 May;1(4):384-97.
Haslett P, Hempstead M, Seidman C, Diakun J, Vasquez D, Freedman VH, Kaplan G. The metabolic and immunologic effects of short-term thalidomide treatment of patients infected with the human immunodeficiency virus. AIDS Res Hum Retroviruses. 1997 Aug 10;13(12):1047-54. doi: 10.1089/aid.1997.13.1047.
Bekker LG, Haslett P, Maartens G, Steyn L, Kaplan G. Thalidomide-induced antigen-specific immune stimulation in patients with human immunodeficiency virus type 1 and tuberculosis. J Infect Dis. 2000 Mar;181(3):954-65. doi: 10.1086/315328.
Klausner JD, Makonkawkeyoon S, Akarasewi P, Nakata K, Kasinrerk W, Corral L, Dewar RL, Lane HC, Freedman VH, Kaplan G. The effect of thalidomide on the pathogenesis of human immunodeficiency virus type 1 and M. tuberculosis infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Mar 1;11(3):247-57. doi: 10.1097/00042560-199603010-00005.
Other Identifiers
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RU-0300395
Identifier Type: -
Identifier Source: secondary_id
199/11682
Identifier Type: -
Identifier Source: org_study_id