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Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swedish International Development Cooperation Agency (SIDA)
Swedish Civil Contingencies Agency (MSB)
Information provided by (Responsible Party):
Per Bjorkman, Lund University
ClinicalTrials.gov Identifier:
NCT01433796
First received: September 11, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

Background: Increased access to antiretroviral therapy (ART) in Africa will require decentralization to primary health care. For this purpose, adapted methods for management of patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in patients starting ART, and assessment of co-administration of ART and TB treatment are priorities in this field.

Aims: To identify clinical predictors of TB in patients starting ART, and to construct screening algorithms for TB in this population; to assess ART outcomes in patients receiving TB treatment at health centre level.

Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of HIV positive patients initiating ART is prospectively followed. Baseline characteristics are registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA levels are followed. Patients with TB are compared to those without TB with regard to ART outcome. Baseline factors associated with TB will be used to construct TB screening algorithms.

Recruitment of the cohort was completed in March 2013; follow-up for determination of long term outcome of ART will be continued until 2016.

Significance: These studies give insight into TB-HIV co-infection at primary health care level in a Sub-Saharan region, and may impact future guidelines for management of such patients.


Condition
HIV Infection
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tuberculosis in HIV-infected Patients Managed in Health Centres in Ethiopia - Identification of a Screening Algorithm for Active Tuberculosis and Determination of Outcome of Combined Antituberculosis and Antiretroviral Treatment

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To develop an algorithm with the potential to identify indicators of prevalent and incident TB among patients initiating ART by correlating baseline clinical signs and symptoms with results of culture- and PCR-based investigations for TB. Such clinical characteristics will be compared both to TB present before starting ART, as well as to TB presenting during the first year after ART initiation. Results from this comparison will be used to construct an algorithm for TB screening in Ethiopian patients eligible for ART.

  • Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. [ Time Frame: Three years ] [ Designated as safety issue: No ]
    To prospectively compare clinical, immunological and virological outcomes of ART in patients with concomitant ATT to those in patients only receiving ART. Specific aims are to study rates of virological suppression during ART, the development of antiretroviral drug resistance, and treatment adherence.


Secondary Outcome Measures:
  • Comparison of diagnostic methods for detection of TB among HIV-infected subjects eligible to start ART. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To compare the diagnostic yields of GeneXpert PCR, smear microscopy and novel tests for the detection of TB among HIV-infected subjects in Ethiopia eligible to start ART, using mycobacterial culture as reference.


Biospecimen Retention:   Samples Without DNA

Aliquoted plasma samples from consenting participants are stored at -80 C for analysis of biomarkers of tuberculosis and for prognostic markers. Stool and urine samples are stored at -20 C for analysis of alternative biomarkers of active tuberculosis.


Enrollment: 812
Study Start Date: October 2011
Estimated Study Completion Date: February 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antiretroviral therapy, tuberculosis
Patients eligible for starting ART in health centres in Ethiopia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-infected patients managed in health centres

Criteria

Inclusion Criteria:

  • HIV infection
  • Fulfills criteria for antiretroviral therapy (CD4 cell count below 350 cells/ml and/or WHO stage IV)
  • Residence in study uptake area
  • Written informed consent to participation and to tracing in case of defaulting

Exclusion Criteria:

  • Ongoing or previous antiretroviral therapy
  • Treatment for active tuberculosis for more than two weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433796

Locations
Ethiopia
Adama Health Centre
Adama, Oromia, Ethiopia
Geda Health Centre
Adama, Oromia, Ethiopia
Dhera Health Center
Dhera, Oromia, Ethiopia
Mojo Health Centre
Mojo, Oromia, Ethiopia
Welenchiti Health Centre
Welenchiti, Oromia, Ethiopia
Sponsors and Collaborators
Lund University
Swedish International Development Cooperation Agency (SIDA)
Swedish Civil Contingencies Agency (MSB)
Investigators
Study Director: Per Björkman, M.D., Associate professor Lund University
Principal Investigator: Taye Tolera Balcha, M.D. Lund University
Study Chair: Erik Sturegård, M.D., Ph.D. Lund University
Study Chair: Patrik Medstrand, Professor Lund University
  More Information

Publications:
Boehme CC, Nabeta P, Hillemann D, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010; 363: 1005-15
Karim SA, Naidoo K, Grobler A, et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med 2010; 362: 697-706

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Bjorkman, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT01433796     History of Changes
Other Study ID Numbers: LU-2010/672, 3120/215/03
Study First Received: September 11, 2011
Last Updated: April 21, 2014
Health Authority: Ethiopia: Ethical Review Committee
Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
antiretroviral therapy
tuberculosis
health centres
Ethiopia

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014