TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)
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First Received Date ICMJE | April 11, 2005 | ||||||||||||
Last Updated Date | June 14, 2011 | ||||||||||||
Start Date ICMJE | June 2005 | ||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00107887 on ClinicalTrials.gov Archive Site | ||||||||||||
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Descriptive Information | |||||||||||||
Brief Title ICMJE | TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy) | ||||||||||||
Official Title ICMJE | Impact of TB Preventive Therapy for HIV/TB Co-infected Patients With Access to Highly Active Antiretroviral Therapy in Rio de Janeiro, Brazil: A Phased Implementation Trial | ||||||||||||
Brief Summary | The purpose of this study is to determine if implementing a policy of widespread INH (Isoniazid) prophylaxis therapy in HIV-infected patients with access to antiretroviral therapy reduces the incidence of active TB disease in the HIV clinic population. |
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Detailed Description | Tuberculosis remains a major public health problem in Brazil. Approximately 35% of HIV-infected adults in Rio de Janeiro are co-infected with latent TB. The Brazilian policies for the provision of treatment to HIV-infected people are among the most progressive in the world. Brazil provides combination antiretroviral therapy free of charge to all patients who meet clinical criteria and maintains an extensive clinic and laboratory system for the appropriate prescription and monitoring of therapy. The use of IPT, however, has been very limited in Brazil and TB remains a prominent disease in AIDS patients. A clustered randomized trial (CRT) will determine if the routine detection of latent TB in HIV-infected patients identified at HIV clinics in Rio de Janeiro, followed by treatment with isoniazid, will reduce TB incidence in this population. The CRT will take a phased-implementation approach to ensure that all clinics will eventually have full coverage. This study will determine if implementing a policy of widespread IPT use in HIV-infected patients with access to ARV therapy reduces the incidence of active TB disease in the HIV clinic population. The study population will be comprised of HIV-infected individuals who attend any of the 29 government HIV clinics in Rio de Janeiro, Brazil. We expect that IPT use in addition to ARVs will result in a 40-60% reduction in TB incidence, and that approximately 50% of the prevented TB cases will be in patients not yet eligible for HAART. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Enrollment ICMJE | 17415 | ||||||||||||
Completion Date | December 2010 | ||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 16 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | Brazil | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00107887 | ||||||||||||
Other Study ID Numbers ICMJE | 19790.01 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
Responsible Party | Dr. Richard Chaisson, Center for Tuberculosis Research, Johns Hopkins University | ||||||||||||
Study Sponsor ICMJE | Johns Hopkins University | ||||||||||||
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Investigators ICMJE |
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Information Provided By | Communicable Disease Program, Brazil | ||||||||||||
Verification Date | June 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |