NCT00107887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,415

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

5.5 years

First QC Date

April 11, 2005

Last Update Submit

June 14, 2011

Conditions

TuberculosisHIV Infections

Keywords

TSTisoniazidHAARTBrazilHIV

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1

NO INTERVENTION

Subjects in clinics that have not received the intervention

2

EXPERIMENTAL

Subjects at clinics that have received the intervention

Drug: INH preventive therapyDrug: TST (tuberculin skin test)

Interventions

INH preventive therapyDRUG

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

2
TST (tuberculin skin test)DRUG

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

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Attending 1 of 29 participating HIV clinics
  • Confirmed HIV infection
  • Age \> 15 years

You may not qualify if:

  • Current active TB disease
  • TB infection within 2 years
  • Hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Rio De Janeiro Health Department Clinics

Rio de Janeiro, Rio de Janeiro, 20211-110, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 19005276BACKGROUND

  • 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.

    PMID: 17589190BACKGROUND

  • 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.

    PMID: 23954450DERIVED

Related Links

MeSH Terms

Conditions

TuberculosisHIV Infections

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Valeria Saraceni, MD

    City of Rio De Janeiro Municipal Health Secretariat

    STUDY DIRECTOR

  • Richard E Chaisson, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Betina Durovni, M.D.

    City of Rio de Janeiro Municipal Health Secretariat

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2005

First Posted

April 12, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

BR(1)