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

February 5, 2014 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone and Francistown, Botswana
        • Gaborone and Francistown Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Isonicotinic Acid Hydrazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incident tuberculosis
Time Frame: During enrolment
During enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: During enrolment
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.
During provision of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

United States Agency for International Development (USAID)
Botswana Ministry of Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-3441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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