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

This study has been completed.
Sponsor:
Collaborators:
Botswana Ministry of Health
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164281
First received: September 9, 2005
Last updated: February 5, 2014
Last verified: February 2014

September 9, 2005
February 5, 2014
November 2004
July 2009   (final data collection date for primary outcome measure)
Incident tuberculosis [ Time Frame: During enrolment ] [ Designated as safety issue: No ]
Active pulmonary or extrapulmonary TB
Complete list of historical versions of study NCT00164281 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: During enrolment ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: During provision of study medication ] [ Designated as safety issue: Yes ]
    After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.
  • 1. The combined endpoint of death and confirmed or probable active TB. Among those who develop active TB, isolates will undergo RFLP analysis.
  • 2. Adverse events
  • 3. Death
Not Provided
Not Provided
 
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Tuberculosis
  • HIV Infections
Drug: Isoniazid
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Other Name: Isonicotinic Acid Hydrazide
Experimental: Continuous vs limited 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).
Intervention: Drug: Isoniazid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
May 2011
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT00164281
CDC-NCHSTP-3441
Yes
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Botswana Ministry of Health
  • United States Agency for International Development (USAID)
Principal Investigator: Taraz Samandari, MD, PHD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP