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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107887
• Other study ID #: 19790.01
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2005
• Last updated: June 14, 2011
• Start date: June 2005
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Communicable Disease Program, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17415
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• INH preventive therapy
Clinics will receive training regarding the use of IPT for prevention of Tuberculosis
• TST (tuberculin skin test)
Clinics will be trained in the use of TST for assessing exposure to TB

Locations

Country	Name	City	State
Brazil	City of Rio De Janeiro Health Department Clinics	Rio de Janeiro

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Bill and Melinda Gates Foundation, Communicable Disease Program, Brazil, Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy		6 Years	No
Primary	Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population		6 Years	No
Secondary	Characteristics of TST+ vs. TST+ HIV-infected patients		6 Years	No
Secondary	Clinical, demographic and laboratory predictors of developing active TB		6 Years	No
Secondary	Lessons learned related to training and implementation		6 Years	No