Clinical trial NCT00107887: TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tuberculosis
HIV Infections
Keywords: TST
isoniazid
HAART
Brazil
HIV
Lead sponsor: Communicable Disease Program, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic
name: Communicable Disease Program, Brazil
name: Bill and Melinda Gates Foundation
First posted: 2005-04-12
Enrollment: 17415
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy
timeFrame: 6 Years
measure: Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population
timeFrame: 6 Years
Secondary outcomes:
measure: Characteristics of TST+ vs. TST+ HIV-infected patients
timeFrame: 6 Years
measure: Clinical, demographic and laboratory predictors of developing active TB
timeFrame: 6 Years
measure: Lessons learned related to training and implementation
timeFrame: 6 Years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: City of Rio De Janeiro Health Department Clinics
Study officials:
affiliation: City of Rio De Janeiro Municipal Health Secretariat
name: Valeria Saraceni, MD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Richard E Chaisson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Rio de Janeiro Municipal Health Secretariat
name: Betina Durovni, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.