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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00865826
First received: March 17, 2009
Last updated: July 20, 2011
Last verified: July 2011

March 17, 2009
July 20, 2011
December 2009
March 2011   (final data collection date for primary outcome measure)
Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865826 on ClinicalTrials.gov Archive Site
  • Prevalence of TB in symptomatic and asymptomatic individuals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Rates of TB drug resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Value of oral candidiasis as a predictor of TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Sputum samples and blood collection

Probability Sample

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

  • HIV Infections
  • Tuberculosis
Other: Standardized diagnostic evaluation
Participants will undergo a diagnostic evaluation for TB at study entry
Other Name: SDE
1
HIV-infected males and females who are not currently receiving ART
Intervention: Other: Standardized diagnostic evaluation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
801
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Peru,   India,   South Africa,   Botswana,   Brazil,   Malawi,   Zimbabwe
 
NCT00865826
ACTG A5253, 1U01AI068636
Not Provided
Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Study Chair: Susan Swindells, MBBS University of Nebraska
Study Chair: Srikanth Tripathy, MBBS National AIDS Research Institute, MIDC, Bhosari
AIDS Clinical Trials Group
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP