Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia
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|ClinicalTrials.gov Identifier: NCT01252537|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : April 23, 2014
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.
|Condition or disease|
|HIV Infection Tuberculosis Immunosuppression|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1200 participants|
|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|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||January 2014|
Initiation of antituberculosis therapy
Patients initiating treatment for tuberculosis with and without HIV co-infection in primary health care centres in Ethiopia
- Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline [ Time Frame: One year ]
- Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline and outcome of tuberculosis treatment [ Time Frame: Two years ]
- Correlation between plasma immune activation markers and degree of immunosuppression [ Time Frame: One year ]
Biospecimen Retention: Samples Without DNA
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): 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|