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Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004276
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
October 18, 1999
October 19, 1999
December 9, 2005
September 1990
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No Changes Posted
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Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
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OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.

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.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • HIV Infections
  • Mycobacterium Infections
  • Tuberculosis
Drug: thalidomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 1999
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PROTOCOL ENTRY 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00004276
199/11682
RU-0300395
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National Center for Research Resources (NCRR)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Rockefeller University
Study Chair: Gilla Kaplan Rockefeller University
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP