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TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)

This study is currently recruiting participants.
Verified by Communicable Disease Program, Brazil, April 2008

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
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Communicable Disease Program, Brazil:

Primary Outcome Measures:
  • Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characteristics of TST+ vs. TST+ HIV-infected patients [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Clinical, demographic and laboratory predictors of developing active TB [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Lessons learned related to training and implementation [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

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
2: Experimental
Subjects at clinics that have received the intervention
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

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Attending 1 of 29 participating HIV clinics
  • Confirmed HIV infection
  • Age >= 16 years

Exclusion Criteria:

  • Current active TB disease
  • TB infection within 2 years
  • Hepatitis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107887

Contacts
Contact: Anne R Efron, MSN, MPH     443-287-2967     aefron@jhmi.edu    
Contact: Jonathan Golub, PhD     443-287-2967     jgolub@jhmi.edu    

Locations
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            

Sponsors and Collaborators
Johns Hopkins University
Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic
Communicable Disease Program, Brazil
Bill and Melinda Gates Foundation

Investigators
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    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by Communicable Disease Program, Brazil:
TST  
isoniazid  
HAART  
Brazil  
HIV  

Study placed in the following topic categories:
Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis
Retroviridae Infections
Immunologic Deficiency Syndromes
Isoniazid

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 23, 2008




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