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Completed

NCT Number: NCT00865826

Observational Study of 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.

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Key information

Conditions

HIV Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Mycobacterium Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Tuberculosis, Pulmonary Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaborone Prevention/Treatment Trials CRS, Gaborone, Botswana

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardized diagnostic evaluation

Other

Participants will undergo a diagnostic evaluation for TB at study entry

Other names: SDE

Primary outcomes

  1. Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB

    Time frame: Throughout study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Network

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2009
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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