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

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ClinicalTrials.gov Identifier: NCT00107887
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : June 15, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Tuberculosis HIV Infections Drug: INH preventive therapy Drug: TST (tuberculin skin test) Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17415 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2005
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Subjects in clinics that have not received the intervention
Experimental: 2
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

Outcome Measures

Primary Outcome Measures :
  1. Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy [ Time Frame: 6 Years ]
  2. Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population [ Time Frame: 6 Years ]

Secondary Outcome Measures :
  1. Characteristics of TST+ vs. TST+ HIV-infected patients [ Time Frame: 6 Years ]
  2. Clinical, demographic and laboratory predictors of developing active TB [ Time Frame: 6 Years ]
  3. Lessons learned related to training and implementation [ Time Frame: 6 Years ]

Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Attending 1 of 29 participating HIV clinics
  • Confirmed HIV infection
  • Age > 15 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107887

City of Rio De Janeiro Health Department Clinics
Rio de Janeiro, Brazil, 20211-110
Sponsors and Collaborators
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
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Richard Chaisson, Center for Tuberculosis Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00107887     History of Changes
Other Study ID Numbers: 19790.01
First Posted: April 12, 2005    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Keywords provided by Communicable Disease Program, Brazil:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections