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

This study has been completed.
Sponsor:
Collaborators:
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004276
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2001
  Purpose

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.


Condition Intervention Phase
HIV Infections
Mycobacterium Infections
Tuberculosis
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 50
Study Start Date: September 1990
Estimated Study Completion Date: June 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004276

Sponsors and Collaborators
Rockefeller University
Investigators
Study Chair: Gilla Kaplan Rockefeller University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004276     History of Changes
Other Study ID Numbers: 199/11682, RU-0300395
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
bacterial infection
human immunodeficiency virus infection
immunologic disorders and infectious disorders
mycobacterium infection
mycobacterium tuberculosis infection
rare disease
viral infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 24, 2014