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

A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

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.

Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid 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.

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