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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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
Groups/Cohorts 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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
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
Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS
Lima, 18, Peru
San Miguel CRS
San Miguel, Lima, Peru
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
Investigators
Study Chair: Susan Swindells, MBBS University of Nebraska
Study Chair: Srikanth Tripathy, MBBS National AIDS Research Institute, MIDC, Bhosari
  More Information

Publications:
Responsible Party: Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
ClinicalTrials.gov Identifier: NCT00865826     History of Changes
Other Study ID Numbers: ACTG A5253, 1U01AI068636
Study First Received: March 17, 2009
Last Updated: July 20, 2011
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Pulmonary Tuberculosis
Myobacterium Infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014