Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment
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ClinicalTrials.gov Identifier: NCT01433796 |
Recruitment Status
:
Completed
First Posted
: September 14, 2011
Last Update Posted
: March 8, 2016
|
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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 or disease |
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HIV Infection Tuberculosis |

Study Type : | Observational |
Actual Enrollment : | 812 participants |
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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | December 2015 |
Group/Cohort |
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Antiretroviral therapy, tuberculosis
Patients eligible for starting ART in health centres in Ethiopia
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- Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. [ Time Frame: Two years ]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 ]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 ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433796
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 |
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 |
Publications:
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 ( Other Identifier: Institute of Science and Technology, Ethiopia ) |
First Posted: | September 14, 2011 Key Record Dates |
Last Update Posted: | March 8, 2016 |
Last Verified: | March 2016 |
Keywords provided by Per Bjorkman, Lund University:
antiretroviral therapy tuberculosis health centres Ethiopia |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |