Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.

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

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Botswana Ministry of Health; United States Agency for International Development (USAID)
• Treatments: Isoniazid

Criteria

Inclusion Criteria:

1. HIV-infected

2. Age >=18 years

3. Tuberculin skin test positive or negative

4. Laboratory:

• Hemoglobin (Hgb) >6.5 gm/dl;

• Neutrophil count >1,000 cells/mm3;

• Platelets >75,000/mm3;

• AST (SGOT) <122 U/L;

• Creatinine <1.5 mg/dl;

• Beta HCG = negative

5. Karnofsky performance status >=60

6. Signed informed consent

Exclusion Criteria:

1. History of TB in the last 3 years or current active TB

2. History of noncompliance to chronic therapies