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

Centers for Disease Control and Prevention1,995 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

1,995

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, Botswana

Outcomes

Primary Outcomes

Number of Participants With Incident Tuberculosis

Incident tuberculosis during follow-up. Tuberculosis cases were categorized as: Definite: ≥1 positive culture for M. tuberculosis or ≥2 sputum smears positive for acid-fast bacilli; Probable: 1 sputum smear or biopsy specimen positive for acid-fast bacilli; Possible: clinical diagnosis with negative or unavailable smear/culture results. Outcome data include definite, probable, and possible tuberculosis cases combined, consistent with the published analysis.

Time frame: During follow-up (36 months)

Secondary Outcomes

Number of Participants Who Died

All-cause mortality during the 36-month follow-up period.

Time frame: During follow-up (36 months)

Tuberculosis and Death Composite Outcome

Composite of incident tuberculosis and all deaths during the 36-month follow-up period. The paper presents this as "Tuberculosis and all deaths."

Time frame: During follow-up (36 months)

Data from ClinicalTrials.gov

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