Status:
COMPLETED
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Botswana Ministry of Health
United States Agency for International Development (USAID)
Conditions:
Tuberculosis
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. ...
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...
Eligibility Criteria
Inclusion
- HIV-infected
- Age \>=18 years
- Tuberculin skin test positive or negative
- 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
- Karnofsky performance status \>=60
- Signed informed consent
Exclusion
- History of TB in the last 3 years or current active TB
- History of noncompliance to chronic therapies
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00164281
Start Date
November 1 2004
End Date
May 1 2011
Last Update
February 6 2014
Active Locations (1)
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1
Gaborone and Francistown Health Clinics
Gaborone and Francistown, Botswana