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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00107887

Collaborator

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

17,415

Enrollment

Location

Arms

Duration (Months)

263.8

Patients Per Site Per Month

Study Details

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

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 :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

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

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

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

Secondary Outcome Measures

Characteristics of TST+ vs. TST+ HIV-infected patients [6 Years]
Clinical, demographic and laboratory predictors of developing active TB [6 Years]
Lessons learned related to training and implementation [6 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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