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

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Status: Completed

Conditions: Tuberculosis; HIV Infections

Treatments: Other: Standardized diagnostic evaluation

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00865826

ACTG A5253

1U01AI068636 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 801 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

801 participants in 1 patient group

1

Description:

HIV-infected males and females who are not currently receiving ART

Treatment:

Other: Standardized diagnostic evaluation