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

CompletedPhase 4

Sponsor: Centers for Disease Control and Prevention

Conditions: Tuberculosis, HIV Infections

Interventions: Isoniazid

Countries: 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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Gaborone, Botswana