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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incident tuberculosis [ Time Frame: During enrolment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  1. History of TB in the last 3 years or current active TB
  2. History of noncompliance to chronic therapies
  Contacts and Locations
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
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

Publications:

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
Health Authority: United States: Federal Government
Botswana: Ministry of Health

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
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014