Thalidomide or Placebo for Mycobacterial and HIV Infections
This study aims to evaluate the effectiveness of Thalidomide as a treatment for individuals with both Mycobacterial and HIV infections.
thalidomide
Blood-Borne Infections+23
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: September 1, 1990
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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