Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 11, 2005
June 14, 2011
June 2005
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy
  • Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population
Complete list of historical versions of study NCT00107887 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Characteristics of TST+ vs. TST+ HIV-infected patients
  • Clinical, demographic and laboratory predictors of developing active TB
  • Lessons learned related to training and implementation
Not Provided
Not Provided
 
TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Tuberculosis
  • HIV Infections
  • 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
  • No Intervention: 1
    Subjects in clinics that have not received the intervention
  • Experimental: 2
    Subjects at clinics that have received the intervention
    Interventions:
    • Drug: INH preventive therapy
    • Drug: TST (tuberculin skin test)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17415
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00107887
19790.01
Yes
Dr. Richard Chaisson, Center for Tuberculosis Research, Johns Hopkins University
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
Communicable Disease Program, Brazil
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP