Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis; HIV Infections
Intervention: Isoniazid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Taraz Samandari, MD, PHD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
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.
Clinical Details
Official title: A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Incident tuberculosis
Secondary outcome: DeathAdverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gaborone and Francistown Health Clinics, Gaborone and Francistown, Botswana
Additional Information
Related 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.
Starting date: November 2004
Last updated: February 5, 2014
|