Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

• ClinicalTrials.gov Identifier: NCT00865826
• Recruitment Status: Completed
• First Posted: March 19, 2009
• Last Update Posted: March 18, 2015
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Tracking Information

• First Submitted Date: March 17, 2009
• First Posted Date: March 19, 2009
• Last Update Posted Date: March 18, 2015
• Study Start Date: December 2009
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 17, 2009): Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [ Time Frame: Throughout study ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 17, 2009)

• Prevalence of TB in symptomatic and asymptomatic individuals [ Time Frame: Throughout study ]
• Rates of TB drug resistance [ Time Frame: Throughout study ]
• Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [ Time Frame: Throughout study ]
• Value of oral candidiasis as a predictor of TB [ Time Frame: Throughout study ]
• Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone [ Time Frame: Throughout study ]
• Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [ Time Frame: Throughout study ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
• Official Title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
• Brief Summary: An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.

Detailed Description

Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where HIV infection has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV prevalence. The primary purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.

This observational study will include participants who are HIV-infected and TB-uninfected and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days. Screening and study entry may occur at the same visit. All evaluations must be performed within 14 days after the participant is registered. Medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of PPD/TST (if available) will occur within this 14-day period.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Sputum samples and blood collection

• Sampling Method: Probability Sample
• Study Population: HIV-infected males and females who are not currently receiving ART

Condition

• HIV Infections
• Tuberculosis

Intervention

Other: Standardized diagnostic evaluation

Participants will undergo a diagnostic evaluation for TB at study entry

Other Name: SDE

Study Groups/Cohorts

1

HIV-infected males and females who are not currently receiving ART

Intervention: Other: Standardized diagnostic evaluation

Publications *

• Aichelburg MC, Rieger A, Breitenecker F, Pfistershammer K, Tittes J, Eltz S, Aichelburg AC, Stingl G, Makristathis A, Kohrgruber N. Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis. 2009 Apr 1;48(7):954-62. doi: 10.1086/597351.
• Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. doi: 10.4103/1596-3519.55680.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 20, 2011): 801
• Original Estimated Enrollment (submitted: March 17, 2009): 800
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• HIV-infected

Exclusion Criteria:

• Receipt of ART within 90 days prior to study entry
• Diagnosis of active TB (pulmonary or extrapulmonary) within 90 days prior to study entry
• Receipt of 7 or more cumulative days of certain medications within 90 days prior to study entry. More information on this criterion can be found in the protocol.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Botswana, Brazil, India, Malawi, Peru, South Africa, Zimbabwe

Administrative Information

• NCT Number: NCT00865826
• Other Study ID Numbers: ACTG A5253; 1U01AI068636 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
• Original Responsible Party: Rona Siskind, DAIDS
• Current Study Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
• Original Study Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Study Chair: Susan Swindells, MBBS; University of Nebraska
• Study Chair: Srikanth Tripathy, MBBS; National AIDS Research Institute, MIDC, Bhosari

• PRS Account: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
• Verification Date: March 2015