Clinical trial NCT00865826: Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Official title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Tuberculosis
Keywords: Pulmonary Tuberculosis
Myobacterium Infections
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2009-03-19
Enrollment: 801
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected males and females who are not currently receiving ART

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.

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 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.

Primary outcomes:
measure: Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB
timeFrame: Throughout study
Secondary outcomes:
measure: Prevalence of TB in symptomatic and asymptomatic individuals
timeFrame: Throughout study
measure: Rates of TB drug resistance
timeFrame: Throughout study
measure: Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts
timeFrame: Throughout study
measure: Value of oral candidiasis as a predictor of TB
timeFrame: Throughout study
measure: 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
timeFrame: Throughout study
measure: Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors
timeFrame: Throughout study
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Gaborone Prevention/Treatment Trials CRS
city: Molepolole
country: Botswana
facility: Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)
city: Manguinhos
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
state: Rio de Janeiro
city: Pune
country: India
facility: BJ Medical College CRS
state: Maharashtra
city: Pune
country: India
facility: NARI Pune CRS
state: Maharashtra
city: Lilongwe
country: Malawi
facility: University of North Carolina Lilongwe CRS
city: San Miguel
country: Peru
facility: San Miguel CRS
state: Lima
city: Lima
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS
city: Johannesburg
country: South Africa
facility: Soweto ACTG CRS
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits HIV CRS
state: Gauteng
city: Durban
country: South Africa
facility: CAPRISA eThekwini CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Durban Adult HIV CRS
state: KwaZulu-Natal
city: Harare
country: Zimbabwe
facility: UZ-Parirenyatwa CRS (30313)
Study officials:
affiliation: University of Nebraska
name: Susan Swindells, MBBS
role: STUDY_CHAIR
affiliation: National AIDS Research Institute, MIDC, Bhosari
name: Srikanth Tripathy, MBBS
role: STUDY_CHAIR
References:
citation: Aichelburg MC, Rieger A, Breitenecker F, Pfistershammer K, Tittes J, Eltz S, Aichelburg AC, Stingl G, Makristathis A, Kohrgruber N. Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis. 2009 Apr 1;48(7):954-62. doi: 10.1086/597351.
citation: Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. doi: 10.4103/1596-3519.55680.