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

NCT01433796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 812

Last updated 2016-03-08

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Swedish International Development Cooperation Agency (SIDA)

    collaborator OTHER_GOV

  • Lund University

    lead OTHER

Principal Investigators

  • Per Björkman, M.D., Associate professor · Lund University

  • Taye Tolera Balcha, M.D. · Lund University

  • Erik Sturegård, M.D., Ph.D. · Lund University

  • Patrik Medstrand, Professor · Lund University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-05-31
Completion
2015-12-31

Countries

  • Ethiopia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433796 on ClinicalTrials.gov