Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia
Background: Tuberculosis (TB) and HIV are leading causes of disease and death in Subsaharan Africa. Antiretroviral therapy (ART) dramatically improves prognosis in HIV infection, but TB is still a common complication in HIV-infected subjects. Management of TB-HIV co-infection is complex, both with regard to diagnosis and treatment. Since scaling-up of ART requires management of most patients in primary health care, it is critical to achieve better strategies for TB-HIV co-infection at peripheral levels of the health care system in endemic regions. This includes development of new methods to assess the severity of HIV disease and the need to start ART during TB treatment in this population.
Aims: To compare a scoring system for clinical signs of immunosuppression with CD4 cell counts to assess HIV disease severity and indications for ART initiation, and to correlate immunosuppression status with treatment outcome.
Workplan: CD4 cell levels and results of clinical scoring has been compared in 1100 patients with TB, using HIV-negative subjects with TB treatment for control. Inclusion was closed in February 2012, and follow-up of participants completed in August 2012. Plasma levels of immune activation and inflammatory markers will be correlated with the degree of immunosuppression.
Significance: TB is the most significant clinical challenge to the successful scaling-up of ART in Africa. In order to improve management in primary health care it is necessary to find robust and reliable techniques for determining disease severity and identification of patients who need to start ART during TB treatment. This study may contribute to increased knowledge in this field and help to modify guidelines for management of TB-HIV co-infection in Ethiopia as well as in other resource-limited settings.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Immunosuppression in HIV-infected Patients With Tuberculosis With Access to Antiretroviral Therapy in Primary Health Care Centres in Ethiopia - Clinical and Immunological Markers and Associations With Treatment Outcome|
- Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
- Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline and outcome of tuberculosis treatment [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Correlation between plasma immune activation markers and degree of immunosuppression [ Time Frame: One year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Aliquoted plasma will be collected from consenting participants and stored at -80 C for analysis of potential prognostic markers reflecting immune activation and inflammation status.
|Study Start Date:||September 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Initiation of antituberculosis therapy
Patients initiating treatment for tuberculosis with and without HIV co-infection in primary health care centres in Ethiopia
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252537
|Adama Health Centre|
|Adama, Oromia, Ethiopia|
|Bishoftu, Oromia, Ethiopia|
|Dukem Health Centre|
|Dukem, Oromia, Ethiopia|
|Mojo Health Centre|
|Mojo, Oromia, Ethiopia|
|Welenchiti Health Centre|
|Welenchiti, Oromia, Ethiopia|
|Principal Investigator:||Per Bjorkman, M.D., Ph.D.||Lund University|