Clinical Trials

MainTitle

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

This study has been completed
Sponsor
AIDS Clinical Trials Group

Collaborator
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
ClinicalTrials.gov Identifier
NCT00865826

First received: March 17, 2009
Last updated: March 17, 2015
Last Verified: March 2015
History of Changes
Purpose

Purpose

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 Intervention
HIV Infections
Tuberculosis

Other : Standardized diagnostic evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures

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

Biospecimen Retention: Samples With DNA
Sputum samples and blood collection

Enrollment: 801
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865826

Locations

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

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

More Information


Responsible Party: AIDS Clinical Trials Group  
ClinicalTrials.gov Identifier: NCT00865826   History of Changes  
Other Study ID Numbers: ACTG A5253  
  1U01AI068636  
Study First Received: March 17, 2009  
Last Updated: March 17, 2015  

Keywords provided by AIDS Clinical Trials Group:

Pulmonary Tuberculosis
Myobacterium Infections

Additional relevant MeSH terms:
Tuberculosis

ClinicalTrials.gov processed this data on March 27, 2020
This information is provided by ClinicalTrials.gov.