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

NCT ID: NCT00865826

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 801 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

HIV Infections; Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

Standardized diagnostic evaluation

Intervention Type: OTHER

Participants will undergo a diagnostic evaluation for TB at study entry

Interventions

Standardized diagnostic evaluation

Participants will undergo a diagnostic evaluation for TB at study entry

Intervention Type: OTHER

Other Intervention Names

SDE

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Swindells, MBBS

Role: STUDY_CHAIR

University of Nebraska

Srikanth Tripathy, MBBS

Role: STUDY_CHAIR

National AIDS Research Institute, MIDC, Bhosari

Locations

Gaborone Prevention/Treatment Trials CRS

Gaborone, , Botswana

Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)

Molepolole, , Botswana

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Manguinhos, Rio de Janeiro, Brazil

BJ Medical College CRS

Pune, Maharashtra, India

NARI Pune CRS

Pune, Maharashtra, India

University of North Carolina Lilongwe CRS

Lilongwe, , Malawi

San Miguel CRS

San Miguel, Lima region, Peru

Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS

Lima, , Peru

Soweto ACTG CRS

Johannesburg, Gauteng, South Africa

Wits HIV CRS

Johannesburg, Gauteng, South Africa

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Durban Adult HIV CRS

Durban, KwaZulu-Natal, South Africa

UZ-Parirenyatwa CRS (30313)

Harare, , Zimbabwe

Countries

Botswana; Brazil; India; Malawi; Peru; South Africa; Zimbabwe

References

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.

Reference Type: BACKGROUND

PMID: 19245343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19143160 (View on PubMed)

Other Identifiers

1U01AI068636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACTG A5253

Identifier Type: -

Identifier Source: org_study_id