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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Centers for Disease Control and Prevention Botswana Ministry of Health U.S. Agency for International Development
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164281

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: Continued vs. Limited isoniazid preventive therapy	Phase IV

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Isoniazid Ftivazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Active pulmonary or extrapulmonary TB

Secondary Outcome Measures:

The combined endpoint of death and confirmed or probable active TB. Among those who develop active TB, isolates will undergo RFLP analysis
Adverse events
Death

Estimated Enrollment:	2000
Study Start Date:	November 2004

Detailed Description:

Randomized, blinded, two-arm comparative trial of continued vs. limited INH 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:

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 Criteria:

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

Contacts and Locations

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

Locations

Botswana
Gaborone P.O. Box 90
Gaborone, Botswana

Sponsors and Collaborators

Centers for Disease Control and Prevention

Botswana Ministry of Health

U.S. Agency for International Development

Investigators

Principal Investigator:

Taraz Samandari, MD, PHD

Centers for Disease Control & Prevention, Atlanta GA

More Information

Study ID Numbers:	CDC-NCHSTP-3441
Study First Received:	September 9, 2005
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00164281
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

Study placed in the following topic categories:

Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis
Retroviridae Infections
Immunologic Deficiency Syndromes
Isoniazid

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Infection

Actinomycetales Infections
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009