Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia

NCT01252537 | Completed

• 1 other identifier: LU 2010/14
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

HIV Infection; Tuberculosis; Immunosuppression

Keywords

HIV; Tuberculosis; Immunosuppression; ART; Ethiopia; Primary health care

Outcome Measures

Primary Outcomes (1)

• Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline

  One year

Secondary Outcomes (2)

• Correlation between degree of immunosuppression measured by clinical scoring and CD4 cell count at baseline and outcome of tuberculosis treatment

  Two years

• Correlation between plasma immune activation markers and degree of immunosuppression

  One year

Study Arms (1)

Initiation of antituberculosis therapy

Patients initiating treatment for tuberculosis with and without HIV co-infection in primary health care centres in Ethiopia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Previous or ongoing antiretroviral therapy
• TB treatment within the preceding six months

Sponsors & Collaborators

• Lund University: lead
• Swedish International Development Cooperation Agency (SIDA): collaborator
• Swedish Agency for Civil Contingencies: collaborator

Study Sites (5)

Adama Health Centre

Ādama, Oromiya, Ethiopia

Location

Bishoftu hospital

Bishoftu, Oromiya, Ethiopia

Location

Dukem Health Centre

Dukem, Oromiya, Ethiopia

Location

Mojo Health Centre

Mojo, Oromiya, Ethiopia

Location

Welenchiti Health Centre

Welenchiti, Oromiya, Ethiopia

Location

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.

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Per Bjorkman, M.D., Ph.D.

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: December 3, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: January 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

ET (5)