Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment
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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 will be 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.
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 |
- 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 will be stored at -80 C for analysis of biomarkers of tuberculosis and for prognostic markers. Stool and urine samples will be stored at -20 C for analysis of alternative biomarkers of active tuberculosis.
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 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 |
HIV-infected patients managed in health centres
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| Contact: Per Björkman, M.D., Ph.D. | +46768111978 | per.bjorkman@med.lu.se |
| Contact: Taye Tolera Balcha, M.D. | +251921609696 | tayetolera@yahoo.com |
| Ethiopia | |
| Adama Health Centre | Recruiting |
| Adama, Oromia, Ethiopia | |
| Contact: Adanech Adanech, HO | |
| Contact: Zewditho Zewditho, BSc Nurse | |
| Principal Investigator: Zewditho Zewditho, BSc Nurse | |
| Sub-Investigator: Ardanech Ardanech, HO | |
| Geda Health Centre | Recruiting |
| Adama, Oromia, Ethiopia | |
| Contact: Baharuddin Baharuddin, HO | |
| Contact: Aragawi Aragawi, HO | |
| Principal Investigator: Baharuddin Baharuddin, HO | |
| Sub-Investigator: Liyat Liyat, HO | |
| Dhera Health Center | Recruiting |
| Dhera, Oromia, Ethiopia | |
| Contact: Khader Khader, Nurse | |
| Contact: Zelalem Zelalem, Nurse | |
| Principal Investigator: Zelalem Zelalem, Nurse | |
| Sub-Investigator: Asenakech Asenakech, Nurse | |
| Mojo Health Centre | Recruiting |
| Mojo, Oromia, Ethiopia | |
| Contact: Senait Senait, HO | |
| Contact: Siraj Siraj, Nurse | |
| Principal Investigator: Senait Senait, HO | |
| Sub-Investigator: Siraj Siraj, Nurse | |
| Welenchiti Health Centre | Recruiting |
| Welenchiti, Oromia, Ethiopia | |
| Contact: Mekdies Asseta, HO | |
| Contact: Birhanu Demissie, HO | |
| Principal Investigator: Mekies Asseta, HO | |
| Sub-Investigator: Birhanu Birhanu, HO | |
| Study Director: | Per Björkman, M.D., Ph.D. | Lund University |
| Principal Investigator: | Taye Tolera Balcha, M.D. | Lund University |
| Study Chair: | Erik Sturegård, M.D., Ph.D. | Lund University |
More Information
Publications:
| 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: | October 20, 2012 |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013