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

June 14, 2011 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17415

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20211-110
        • City of Rio De Janeiro Health Department Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Characteristics of TST+ vs. TST+ HIV-infected patients
Time Frame: 6 Years
6 Years
Clinical, demographic and laboratory predictors of developing active TB
Time Frame: 6 Years
6 Years
Lessons learned related to training and implementation
Time Frame: 6 Years
6 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Bill and Melinda Gates Foundation
Communicable Disease Program, Brazil
Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 11, 2005

First Submitted That Met QC Criteria

April 11, 2005

First Posted (Estimate)

April 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19790.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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