Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Centers for Disease Control and Prevention

Collaborator
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
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Tuberculosis
HIV Infections

Drug : Isoniazid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures

  • Incident tuberculosis [ Time Frame: During enrolment ]
Secondary Outcome Measures:
  • Death [ Time Frame: During enrolment ]
  • Adverse events [ Time Frame: During provision of study medication ]
    After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.

Enrollment: 2000
Study Start Date: November 2004
Study Completion Date: May 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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).
Drug: Isoniazid

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

Other Name: Isonicotinic Acid Hydrazide

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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:
  • History of TB in the last 3 years or current active TB
  • History of noncompliance to chronic therapies

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00164281

    Locations

    Botswana
    Gaborone and Francistown Health Clinics
    Gaborone and Francistown, Botswana

    Sponsors and Collaborators

    Centers for Disease Control and Prevention
    Botswana Ministry of Health
    United States Agency for International Development (USAID)

    Investigators

    Principal Investigator: Taraz Samandari, MD, PHD Centers for Disease Control and Prevention
    More Information

    More Information

    Additional Information:

    Video webcast of preliminary results by Dr. T. Samandari on Feb 18, 2010

    Responsible Party: Centers for Disease Control and Prevention  
    ClinicalTrials.gov Identifier: NCT00164281   History of Changes  
    Other Study ID Numbers: CDC-NCHSTP-3441  
    Study First Received: September 9, 2005  
    Last Updated: February 5, 2014  

    Keywords provided by Centers for Disease Control and Prevention:

    TB
    Tuberculosis
    INH
    Isoniazid
    Preventive therapy
    HIV
    AIDS
    Botswana
    LTBI
    Latent TB Infection

    Additional relevant MeSH terms:
    HIV Infections
    Tuberculosis
    Isoniazid

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.