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

Phase 4

Completed

• Conditions: HIV Infections; Tuberculosis
• Interventions: Drug: Isoniazid

• Registration Number: NCT00164281
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2009-07
• Study Completion: 2011-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous vs limited isoniazid	Isoniazid	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).

Primary Outcome Measures

Name	Time	Method
Incident tuberculosis	During enrolment

Secondary Outcome Measures

Name	Time	Method
Death	During enrolment
Adverse events	During provision of study medication	After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.

Trial Locations

Locations (1)

Gaborone and Francistown Health Clinics; 🇧🇼 Gaborone and Francistown, Botswana