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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865826
• Other study ID #: ACTG A5253
• Secondary ID: 1U01AI068636
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: March 17, 2015
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Other:
• Standardized diagnostic evaluation
Participants will undergo a diagnostic evaluation for TB at study entry

Locations

Country	Name	City	State
Botswana	Gaborone Prevention/Treatment Trials CRS	Gaborone
Botswana	Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)	Molepolole
Brazil	Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS	Manguinhos	Rio de Janeiro
India	BJ Medical College CRS	Pune	Maharashtra
India	NARI Pune CRS	Pune	Maharashtra
Malawi	University of North Carolina Lilongwe CRS	Lilongwe
Peru	Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS	Lima
Peru	San Miguel CRS	San Miguel	Lima
South Africa	CAPRISA eThekwini CRS	Durban	KwaZulu-Natal
South Africa	Durban Adult HIV CRS	Durban	KwaZulu-Natal
South Africa	Soweto ACTG CRS	Johannesburg	Gauteng
South Africa	Wits HIV CRS	Johannesburg	Gauteng
Zimbabwe	UZ-Parirenyatwa CRS (30313)	Harare

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR)

Countries where clinical trial is conducted

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

References & 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. — View Citation

Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB		Throughout study	No
Secondary	Prevalence of TB in symptomatic and asymptomatic individuals		Throughout study	No
Secondary	Rates of TB drug resistance		Throughout study	No
Secondary	Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts		Throughout study	No
Secondary	Value of oral candidiasis as a predictor of TB		Throughout study	No
Secondary	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	No
Secondary	Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors		Throughout study	No