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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004276

Enrollment

Registered

1999-10-19

Start date

1990-09-30

Completion date

1999-06-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Mycobacterium Infections, Tuberculosis

Keywords

bacterial infection, human immunodeficiency virus infection, immunologic disorders and infectious disorders, mycobacterium infection, mycobacterium tuberculosis infection, rare disease, viral infection

Brief summary

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.

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.

Interventions

DRUGthalidomide

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026