Treatment of Latent Tuberculosis Infection With Isoniazid

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effect that treatment of dormant tuberculosis infection has on the immunological system.

We expect to observe an impact over the production of cytokines by peripheral white blood cells which may be useful to know if treatment has been effective.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: Bill and Melinda Gates Foundation; Wellcome Trust
• Treatments: Isoniazid

Criteria

Inclusion criteria:

• Informed consent

• Age 10-45

• Either sex

• Resident in study area

• Documented TST+ve (>10mm, Mantoux method, 2TU, PPD Statens Serum Institute)

• Normal chest radiograph

• HIV negative test

Exclusion criteria:

• Active tuberculosis

• Previous diagnosis of tuberculosis

• Treatment for active or latent tuberculosis

• Contact with TB patients harboring MDR or INH resistant isolates of Mtb

• Diseases or therapies associated with immunosuppression

• Diabetes mellitus

• Abnormal liver enzyme levels.

• HB below 8gr/dl

• Pregnancy (ascertained by urinary β-HCG)

• Allergy or intolerance to isoniazid

• Peripheral neuropathy

• Ingestion of drugs interacting with isoniazid