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Trial record 1 of 1 for:    A5253
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Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

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ClinicalTrials.gov Identifier: NCT00865826
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 18, 2015
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Description
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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.

Condition or disease Intervention/treatment
HIV Infections Tuberculosis Other: Standardized diagnostic evaluation

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 Design
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Study Type : Observational
Actual Enrollment : 801 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1
HIV-infected males and females who are not currently receiving ART
 Other: Standardized diagnostic evaluation
Participants will undergo a diagnostic evaluation for TB at study entry
Other Name: SDE


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Prevalence of TB in symptomatic and asymptomatic individuals [ Time Frame: Throughout study ]
  2. Rates of TB drug resistance [ Time Frame: Throughout study ]
  3. Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [ Time Frame: Throughout study ]
  4. Value of oral candidiasis as a predictor of TB [ Time Frame: Throughout study ]
  5. 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 ]
  6. Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [ Time Frame: Throughout study ]

Biospecimen Retention:   Samples With DNA
Sputum samples and blood collection

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected males and females who are not currently receiving ART
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865826


Locations
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Botswana
Gaborone Prevention/Treatment Trials CRS
Gaborone, Botswana
Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)
Molepolole, Botswana
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Manguinhos, Rio de Janeiro, Brazil
India
BJ Medical College CRS
Pune, Maharashtra, India, 411001
NARI Pune CRS
Pune, Maharashtra, India, 411026
Malawi
University of North Carolina Lilongwe CRS
Lilongwe, Malawi
Peru
San Miguel CRS
San Miguel, Lima, Peru
Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS
Lima, Peru, 18
South Africa
Soweto ACTG CRS
Johannesburg, Gauteng, South Africa, 1864
Wits HIV CRS
Johannesburg, Gauteng, South Africa
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, South Africa, 4011
Durban Adult HIV CRS
Durban, KwaZulu-Natal, South Africa
Zimbabwe
UZ-Parirenyatwa CRS (30313)
Harare, Zimbabwe
Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Study Chair: Susan Swindells, MBBS University of Nebraska
Study Chair: Srikanth Tripathy, MBBS National AIDS Research Institute, MIDC, Bhosari
More Information
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Publications:

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Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00865826    
Other Study ID Numbers: ACTG A5253
1U01AI068636 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by AIDS Clinical Trials Group:
Pulmonary Tuberculosis
Myobacterium Infections
Additional relevant MeSH terms:
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Tuberculosis
Infections
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses