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

NCT ID: NCT00107887

Last Updated: 2011-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Tuberculosis; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Subjects in clinics that have not received the intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Subjects at clinics that have received the intervention

Group Type: EXPERIMENTAL

INH preventive therapy

Intervention Type: DRUG

Clinics will receive training regarding the use of IPT for prevention of Tuberculosis

TST (tuberculin skin test)

Intervention Type: DRUG

Clinics will be trained in the use of TST for assessing exposure to TB

Interventions

INH preventive therapy

Clinics will receive training regarding the use of IPT for prevention of Tuberculosis

Intervention Type: DRUG

TST (tuberculin skin test)

Clinics will be trained in the use of TST for assessing exposure to TB

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic

OTHER

Sponsor Role: collaborator

Communicable Disease Program, Brazil

OTHER_GOV

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Center for Tuberculosis Research, Johns Hopkins University

Principal Investigators

Valeria Saraceni, MD

Role: STUDY_DIRECTOR

City of Rio De Janeiro Municipal Health Secretariat

Richard E Chaisson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Betina Durovni, M.D.

Role: STUDY_CHAIR

City of Rio de Janeiro Municipal Health Secretariat

Locations

City of Rio De Janeiro Health Department Clinics

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Golub JE, Durovni B, King BS, Cavalacante SC, Pacheco AG, Moulton LH, Moore RD, Chaisson RE, Saraceni V. Recurrent tuberculosis in HIV-infected patients in Rio de Janeiro, Brazil. AIDS. 2008 Nov 30;22(18):2527-33. doi: 10.1097/QAD.0b013e328311ac4e.

Reference Type: BACKGROUND

PMID: 19005276 (View on PubMed)

Golub JE, Saraceni V, Cavalcante SC, Pacheco AG, Moulton LH, King BS, Efron A, Moore RD, Chaisson RE, Durovni B. The impact of antiretroviral therapy and isoniazid preventive therapy on tuberculosis incidence in HIV-infected patients in Rio de Janeiro, Brazil. AIDS. 2007 Jul 11;21(11):1441-8. doi: 10.1097/QAD.0b013e328216f441.

Reference Type: BACKGROUND

PMID: 17589190 (View on PubMed)

Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, Cohn S, Efron A, Chaisson RE, Golub JE. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013 Oct;13(10):852-8. doi: 10.1016/S1473-3099(13)70187-7. Epub 2013 Aug 16.

Reference Type: DERIVED

PMID: 23954450 (View on PubMed)

Related Links

http://www.tbhiv-create.org

Related Info

Other Identifiers

19790.01

Identifier Type: -

Identifier Source: org_study_id