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

HIV Infections Clinical Trial

Official title:

A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164281
• Other study ID #: CDC-NCHSTP-3441
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 5, 2014
• Start date: November 2004
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentBotswana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• Isoniazid
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.

Locations

Country	Name	City	State
Botswana	Gaborone and Francistown Health Clinics	Gaborone and Francistown

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Botswana Ministry of Health, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Botswana, 

References & Publications (9)

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. — View Citation

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. — View Citation

Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS One. 2011;6(10):e22696. doi: 10.1371/journal.pone.0022696. — View Citation

Gust DA, Mosimaneotsile B, Mathebula U, Chingapane B, Gaul Z, Pals SL, Samandari T. Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana. PLoS One. 2011 Apr 25;6(4):e18435. doi: 10.1371/journal.pone.0018435. — View Citation

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. — View Citation

Samandari T, Agizew TB, Nyirenda S, Tedla Z, Sibanda T, Shang N, Mosimaneotsile B, Motsamai OI, Bozeman L, Davis MK, Talbot EA, Moeti TL, Moffat HJ, Kilmarx PH, Castro KG, Wells CD. 6-month versus 36-month isoniazid preventive treatment for tuberculosis i — View Citation

Sibanda T, Tedla Z, Nyirenda S, Agizew T, Marape M, Miranda AG, Reuter H, Johnson JL, Samandari T. Anti-tuberculosis treatment outcomes in HIV-infected adults exposed to isoniazid preventive therapy in Botswana. Int J Tuberc Lung Dis. 2013 Feb;17(2):178-8 — View Citation

Taylor AW, Mosimaneotsile B, Mathebula U, Mathoma A, Moathlodi R, Theebetsile I, Samandari T. Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. Infect Dis Obstet Gynecol. 2013;2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident tuberculosis		During enrolment	No
Secondary	Death		During enrolment	Yes
Secondary	Adverse events	After enrolment, half of the participants will receive isoniazid for 6 months and the other half for 36 months.	During provision of study medication	Yes

External Links

•   Video webcast of preliminary results by Dr. T. Samandari on Feb 18, 2010