TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tuberculosis HIV Infections |
Drug: INH preventive therapy Drug: TST (tuberculin skin test) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
- Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Characteristics of TST+ vs. TST+ HIV-infected patients [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Clinical, demographic and laboratory predictors of developing active TB [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Lessons learned related to training and implementation [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
| Enrollment: | 17415 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Brazil | |
| City of Rio De Janeiro Health Department Clinics | |
| Rio de Janeiro, Brazil, 20211-110 | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Richard Chaisson, Center for Tuberculosis Research, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00107887 History of Changes |
| Other Study ID Numbers: | 19790.01 |
| Study First Received: | April 11, 2005 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United States: Institutional Review Board Brazil: National Committee of Ethics in Research |
Keywords provided by Communicable Disease Program, Brazil:
|
TST isoniazid HAART Brazil HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013
