Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia

This study has been completed.
Sponsor:
Collaborators:
Swedish International Development Cooperation Agency (SIDA)
Swedish Agency for Civil Contingencies
Information provided by (Responsible Party):
Per Bjorkman, Lund University
ClinicalTrials.gov Identifier:
NCT01252537
First received: September 8, 2010
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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
HIV Infection
Tuberculosis
Immunosuppression

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 1200
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients initiating treatment for tuberculosis in primary health centres providing integrated TB-HIV care in Oromia region, Ethiopia

Criteria

Inclusion Criteria:

  • Diagnosis of tuberculosis
  • Not having received TB treatment for more than two weeks
  • Consent to HIV testing

Exclusion Criteria:

  • Previous or ongoing antiretroviral therapy
  • TB treatment within the preceding six months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252537

Locations
Ethiopia
Adama Health Centre
Adama, Oromia, Ethiopia
Bishoftu hospital
Bishoftu, Oromia, Ethiopia
Dukem Health Centre
Dukem, Oromia, Ethiopia
Mojo Health Centre
Mojo, Oromia, Ethiopia
Welenchiti Health Centre
Welenchiti, Oromia, Ethiopia
Sponsors and Collaborators
Lund University
Swedish International Development Cooperation Agency (SIDA)
Swedish Agency for Civil Contingencies
Investigators
Principal Investigator: Per Bjorkman, M.D., Ph.D. Lund University
  More Information

No publications provided

Responsible Party: Per Bjorkman, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT01252537     History of Changes
Other Study ID Numbers: LU 2010/14
Study First Received: September 8, 2010
Last Updated: April 21, 2014
Health Authority: Ethiopia: Ethical Review Committee
Sweden: Institutional Review Board

Keywords provided by Lund University:
HIV
Tuberculosis
Immunosuppression
ART
Ethiopia
Primary health care

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 September 22, 2014