Phase 2
18 Years
65 Years
Not Enrolling
Both
HIV Infections, Mycobacterium Infections, Tuberculosis

Thank you

Trial Information


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Gilla Kaplan

Investigator Role:

Study Chair

Investigator Affiliation:

Rockefeller University

Authority:

United States: Federal Government

Study ID:

199/11682

NCT ID:

NCT00004276

Start Date:

September 1990

Completion Date:

June 1999

Related Keywords:

  • HIV Infections
  • Mycobacterium Infections
  • Tuberculosis
  • bacterial infection
  • human immunodeficiency virus infection
  • immunologic disorders and infectious disorders
  • mycobacterium infection
  • mycobacterium tuberculosis infection
  • rare disease
  • viral infection
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Tuberculosis

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