Optimizing Clinical Outcomes in HIV-Infected Adults & Children

HIV Clinical Trial

Official title:

CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043080
• Other study ID #: 12-1402
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: August 2, 2017
• Start date: August 2012
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB diagnosis.

Description:

This study will evaluate Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) as the first-line Tuberculosis (TB) diagnostic test in Human Immunodeficiency Virus (HIV)-infected adults and pediatric patients in peri-urban settings and determine its impact on accurate case detection and treatment initiation in these settings. In addition, the Determine TB-Lipoarabinomannan (LAM) Ag® will be used to model added diagnostic value when used alone or in combination with Xpert MTB/RIF, within the TB diagnostic algorithm for HIV infected patients in Zambia.

A quasi-experimental "before-after" study design will be used at two similar peri-urban district hospitals. Each site will initially implement the Standard of Care (SOC) phase, in which a prospective cohort of HIV-infected adult and pediatric TB suspects will be screened for TB according to the current standard of care in Zambian HIV care clinics. This will be followed by a 4-week "intervention wash-out" period to allow completion of the diagnostic work-up of all patients recruited during the last month of the SOC phase.

The second phase (Xpert MTB/RIF phase) will start immediately following the "intervention wash-out" period. In this phase, a second cohort of HIV-infected adult and pediatric TB suspects will be screened for TB using the Xpert MTB/RIF algorithm. Each phase will last approximately 6 months, or until the target sample size for adults is reached. Mycobacterial culture will be performed during the study to confirm TB diagnosis and determine whether appropriate treatment was given. "Appropriate treatment" means the patient was initiated on ATT within 4 weeks of screening initiation for culture-positive patients or a correct diagnosis of not having TB in culture-negative patients. Culture results will be released from the CIDRZ Lab for patient care as soon as results are available.

During both study phases participants will be asked to submit a urine sample for testing with the Determine TB-LAM Ag® assay. Urine specimens will be collected at the study site and all procedures will be carried out at the CIDRZ Central Laboratory in Lusaka using standard laboratory protocols and quality assurance procedures. Since Determine TB-LAM Ag® has not yet been endorsed by the World Health Organization (WHO) nor approved by the Zambian Ministry of Health for TB diagnosis, results from the Determine TB-LAM Ag® assay will not be used for patient care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1436
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

Inclusion Criteria:

• Aged 15 years or above ("Adult"), or less than 15 years old ("Child") ;

• HIV-infected and enrolled in HIV care at Chongwe and Kafue District Hospitals

• Intends to continue receiving care at the district hospital for at least 6 months.

• TB suspects according to Zambian National Guidelines [31] ;

• Willing to provide signed informed consent (or parental consent, if the participant is under 18);

• Willing (or parent or guardian willing) to provide locator information and allow contact by phone or home visit

Exclusion Criteria:

• Diagnosed with TB within the last 6 months or taken TB treatment in the last 3 months

• Enrolled in another study which might interfere with study objectives (ex. TB-HAART)

Related Conditions & MeSH terms

• HIV
• Tuberculosis
• Tuberculosis Diagnosis

Intervention

Other:
• Xpert MTB/RIF Tuberculosis diagnostic tool
This is s new diagnostic tool that has been approved by WHO for the diagnosis of TB in HIV-infected patients in resource limited settings

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Zambia, 

References & Publications (38)

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Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S, Dawson R, Whitelaw A, Hoelscher M, Sharma S, Pai M, Warren R, Dheda K. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011 Jul 1;184(1):132-40. doi: 10.1164/rccm.201101-0056OC. Epub 2011 Apr 14. — View Citation

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic performance of Xpert MTB/RIF	Sensitivity, specificity, positive and negative predictive values of TB diagnosis with Xpert MTB/RIF compared to culture will be calculated.	screening visit, 3 and 6 months post screening
Primary	Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase	proportions of adult and pediatric patients receiving appropriate TB treatment in each study phase, using mycobacterial culture as the reference standard, and the feasibility and cost effectiveness of Xpert MTB/RIF in this setting	within 4 weeks of initiation
Secondary	Clinical outcomes of subjects screened using the Xpert MTB/RIF algorithm compared to existing standard of care.	Clinical outcomes to be compared include (but are not limited to): ART treatment start date CD4 response TB treatment outcomes at 6 months post-diagnosis Mortality Co-morbidities Other Opportunistic Infections Characteristics of TB patients who initially test Xpert negative (Xpert- /Culture + patients)	3 and 6 months post TB-screening

External Links

•   University of North Carolina website