Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
This study is ongoing, but not recruiting participants.
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: September 26, 2012
Last verified: September 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Isoniazid
U.S. FDA Resources
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 |
Estimated Study Completion Date: | July 2013 |
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.
![](https://webarchive.library.unt.edu/web/20130305100932im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130305100932im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
![](https://webarchive.library.unt.edu/web/20130305100932im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | September 26, 2012 |
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 March 03, 2013