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Sponsors and Collaborators: |
Johns Hopkins University Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic Communicable Disease Program, Brazil Bill and Melinda Gates Foundation |
Information provided by: | Communicable Disease Program, Brazil |
ClinicalTrials.gov Identifier: | NCT00107887 |
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.
Condition | Intervention | Phase |
Tuberculosis HIV Infections |
Drug: INH preventive therapy Drug: TST (tuberculin skin test) |
Phase IV |
MedlinePlus related topics: | AIDS AIDS Medicines Tuberculosis |
ChemIDplus related topics: | Isoniazid Tuberculin Purified Protein Derivative Ftivazide |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15000 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: No Intervention
Subjects in clinics that have not received the intervention
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2: Experimental
Subjects at clinics that have received the intervention
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Drug: INH preventive therapy
Clinics will receive training regarding the use of IPT for prevention of Tuberculosis
Drug: TST (tuberculin skin test)
Clinics will be trained in the use of TST for assessing exposure to TB
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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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne R Efron, MSN, MPH | 443-287-2967 | aefron@jhmi.edu |
Contact: Jonathan Golub, PhD | 443-287-2967 | jgolub@jhmi.edu |
Brazil | |||||
City of Rio De Janeiro Health Department Clinics | Recruiting | ||||
Rio de Janeiro, Brazil, 20211-110 | |||||
Contact: Valeria Saraceni +1 55 21 2293-8665 vsaraceni@rio.rj.gov.br | |||||
Principal Investigator: Betina Durovni, MD | |||||
Sub-Investigator: Solange Cavalcanti, MD, MPH | |||||
Sub-Investigator: Antonio Pacheco, MD | |||||
Sub-Investigator: Valeria Saraceni, MD |
Johns Hopkins University |
Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic |
Communicable Disease Program, Brazil |
Bill and Melinda Gates Foundation |
Study Director: | Valeria Saraceni, MD | City of Rio De Janeiro Municipal Health Secretariat |
Principal Investigator: | Richard E Chaisson, M.D. | Johns Hopkins University |
Study Chair: | Betina Durovni, M.D. | City of Rio de Janeiro Municipal Health Secretariat |
Related Info 
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Responsible Party: | Center for Tuberculosis Research, Johns Hopkins University ( Dr. Richard Chaisson ) |
Study ID Numbers: | 19790.01 |
First Received: | April 11, 2005 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00107887 |
Health Authority: | United States: Institutional Review Board; Brazil: National Committee of Ethics in Research |
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