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

NCT00865826 | Completed

• 2 other identifiers: ACTG A52531U01AI068636
• Study Type: observational
• Target: 801
• Locations: 7 countries
• Sites: 13

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.

Conditions

HIV Infections; Tuberculosis

Keywords

Pulmonary Tuberculosis; Myobacterium Infections

Outcome Measures

Primary Outcomes (1)

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

  Throughout study

Secondary Outcomes (6)

• Prevalence of TB in symptomatic and asymptomatic individuals

  Throughout study

• Rates of TB drug resistance

  Throughout study

• Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts

  Throughout study

• Value of oral candidiasis as a predictor of TB

  Throughout study

• 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

  Throughout study

Study Arms (1)

1

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

Other: Standardized diagnostic evaluation

Interventions

Standardized diagnostic evaluation OTHER

Participants will undergo a diagnostic evaluation for TB at study entry

Also known as: SDE

1

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• HIV-infected

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (13)

Gaborone Prevention/Treatment Trials CRS

Gaborone, Botswana

Location

Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)

Molepolole, Botswana

Location

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Manguinhos, Rio de Janeiro, Brazil

Location

BJ Medical College CRS

Pune, Maharashtra, 411001, India

Location

NARI Pune CRS

Pune, Maharashtra, 411026, India

Location

University of North Carolina Lilongwe CRS

Lilongwe, Malawi

Location

San Miguel CRS

San Miguel, Lima region, Peru

Location

Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS

Lima, 18, Peru

Location

Soweto ACTG CRS

Johannesburg, Gauteng, 1864, South Africa

Location

Wits HIV CRS

Johannesburg, Gauteng, South Africa

Location

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, 4011, South Africa

Location

Durban Adult HIV CRS

Durban, KwaZulu-Natal, South Africa

Location

UZ-Parirenyatwa CRS (30313)

Harare, Zimbabwe

Location

Related Publications (2)

• 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.

  PMID: 19245343 BACKGROUND

• 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.

  PMID: 19143160 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sputum samples and blood collection

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan Swindells, MBBS

  University of Nebraska

  STUDY CHAIR

• Srikanth Tripathy, MBBS

  National AIDS Research Institute, MIDC, Bhosari

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

MA (1); IN (2); ZI (1); PE (2); BO (2); ZA (4); BR (1)