Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
NCT ID: NCT00164281
Last Updated: 2014-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2000 participants
INTERVENTIONAL
2004-11-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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).
Isoniazid
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Interventions
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Isoniazid
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. History of noncompliance to chronic therapies
18 Years
ALL
No
Sponsors
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Botswana Ministry of Health
OTHER_GOV
United States Agency for International Development (USAID)
FED
Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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Taraz Samandari, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Locations
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Gaborone and Francistown Health Clinics
Gaborone and Francistown, , Botswana
Countries
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References
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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.
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 in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 May 7;377(9777):1588-98. doi: 10.1016/S0140-6736(11)60204-3. Epub 2011 Apr 12.
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.
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. Epub 2011 Oct 27.
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):178-85. doi: 10.5588/ijtld.12.0314.
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;2013:195637. doi: 10.1155/2013/195637. Epub 2013 Mar 7.
Tedla Z, Nguyen ML, Sibanda T, Nyirenda S, Agizew TB, Girde S, Rose CE, Samandari T. Isoniazid-associated hepatitis in adults infected with HIV receiving 36 months of isoniazid prophylaxis in Botswana. Chest. 2015 May;147(5):1376-1384. doi: 10.1378/chest.14-0215.
Related Links
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Video webcast of preliminary results by Dr. T. Samandari on Feb 18, 2010
Other Identifiers
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CDC-NCHSTP-3441
Identifier Type: -
Identifier Source: org_study_id
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