Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment
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.
|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|
- 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.
- 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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||February 2016|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Antiretroviral therapy, tuberculosis
Patients eligible for starting ART in health centres in Ethiopia
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433796
|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|
|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|