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

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 4

Conditions: Tuberculosis; HIV Infections

Treatments: Drug: Isoniazid

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00164281

CDC-NCHSTP-3441

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2,000 participants in 1 patient group

Continuous vs limited isoniazid

Experimental group

Description:

The placebo arm will receive 6 months of open label isoniazid before beginning placebo (as a coded medication). The treatment (experimental arm) will receive 6 months of open label isoniazid before beginning coded medication (isoniazid).

Treatment:

Drug: Isoniazid