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

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00164281
• Collaborator: Botswana Ministry of Health (Other), United States Agency for International Development (USAID) (U.S. Fed)
• Enrollment: 2,000
• Location: 1
• Arm: 1
• Duration (Months): 77.9
• Patients Per Site Per Month: 25.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Tuberculosis; HIV Infections	Drug: Isoniazid	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 2000 participants
• 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
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incident tuberculosis [During enrolment]

Secondary Outcome Measures

1. Death [During enrolment]

2. Adverse events [During provision of study medication]

   After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.

Eligibility Criteria

Criteria

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

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

1. Karnofsky performance status >=60

2. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Agizew T, Bachhuber MA, Nyirenda S, Makwaruzi VZ, Tedla Z, Tallaksen RJ, Parker JE, Mboya JJ, Samandari T. Association of chest radiographic abnormalities with tuberculosis disease in asymptomatic HIV-infected adults. Int J Tuberc Lung Dis. 2010 Mar;14(3):324-31.
• Agizew TB, Arwady MA, Yoon JC, Nyirenda S, Mosimaneotsile B, Tedla Z, Motsamai O, Kilmarx PH, Wells CD, Samandari T. Tuberculosis in asymptomatic HIV-infected adults with abnormal chest radiographs screened for tuberculosis prevention. Int J Tuberc Lung Dis. 2010 Jan;14(1):45-51.
• Mosimaneotsile B, Mathoma A, Chengeta B, Nyirenda S, Agizew TB, Tedla Z, Motsamai OI, Kilmarx PH, Wells CD, Samandari T. Isoniazid tuberculosis preventive therapy in HIV-infected adults accessing antiretroviral therapy: a Botswana Experience, 2004-2006. J Acquir Immune Defic Syndr. 2010 May 1;54(1):71-7. doi: 10.1097/QAI.0b013e3181c3cbf0.
• Tedla Z, Nyirenda S, Peeler C, Agizew T, Sibanda T, Motsamai O, Vernon A, Wells CD, Samandari T. Isoniazid-associated hepatitis and antiretroviral drugs during tuberculosis prophylaxis in hiv-infected adults in Botswana. Am J Respir Crit Care Med. 2010 Jul 15;182(2):278-85. doi: 10.1164/rccm.200911-1783OC. Epub 2010 Apr 8.

• Responsible Party: Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT00164281
• Other Study ID Numbers: CDC-NCHSTP-3441
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 6, 2014
• Last Verified: Feb 1, 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: Tuberculosis; Isoniazid

Study Results

No Results Posted as of Feb 6, 2014