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

Centers for Disease Control and Prevention2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

2,000

Conditions

Tuberculosis HIV Infections

Interventions

IsoniazidDRUG

Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 and Francistown Health Clinics

Gaborone and Francistown, Botswana

Outcomes

Primary Outcomes

Incident tuberculosis

Time frame: During enrolment

Secondary Outcomes

Death

Time frame: During enrolment

Adverse events

After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.

Time frame: During provision of study medication

Data from ClinicalTrials.gov

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