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

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 11, 2005
Last updated: June 14, 2011
Last verified: June 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 17415
Study Start Date: June 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 > 15 years

Exclusion Criteria:

  • Current active TB disease
  • TB infection within 2 years
  • Hepatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
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
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

Additional Information:
Publications:
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
Study First Received: April 11, 2005
Last Updated: June 14, 2011
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

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

ClinicalTrials.gov processed this record on August 28, 2014