Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group protocol A5253

Citation: Swindells S, Komarow L, Tripathy S, Cain KP,  MacGregor RR, Achkar JM, Gupta A, Veloso VG, Asmelash A,  Omoz-Oarhe AE, Gengiah S, Lalloo U, Allen R, Shiboski C, Anderson J, Qasba SS, Katzenstein DK for the AIDS Clinical Trials Group A5253 Study Team. Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group protocol A5253. Int J Tuberc Lung Dis. 2013 Apr;17(4):532-9. doi: 10.5588/ijtld.12.0737. PMID: 23485388. PMCID: PMC3923622.

Access full article:

http://www.ncbi.nlm.nih.gov/pubmed/23485388

BACKGROUND:

Improved tuberculosis (TB) screening is urgently needed for human immunodeficiency virus (HIV) infected patients.

METHODS:

An observational, multi-country, cross-sectional study of HIV-infected patients to compare a standardized diagnostic evaluation (SDE) for TB with standard of care (SOC). SOC evaluations included TB symptom review (current cough, fever, night sweats and/or weight loss), sputum Ziehl-Neelsen staining and chest radiography. SDE screening added extended clinical signs and symptoms and fluorescent microscopy (FM). All participants underwent all evaluations. Mycobacterium tuberculosis on sputum culture was the primary outcome.

RESULTS:

A total of 801 participants were enrolled from Botswana, Malawi, South Africa, Zimbabwe, India, Peru and Brazil. The median age was 33 years; 37% were male, and median CD4 count was 275 cells/mm(3). Thirty-one participants (4%) had a positive culture on Löwenstein-Jensen media and 54 (8%) on MGIT. All but one positive culture came from sub-Saharan Africa, where the prevalence of TB was 54/445 (12%). SOC screening had 54% sensitivity (95%CI 40-67) and 76% specificity (95%CI 72-80). Positive and negative predictive values were respectively 24% and 92%. No elements of the SDE improved the predictive values of SOC.

CONCLUSIONS:

Symptom-based screening with smear microscopy was insufficiently sensitive. More sensitive diagnostic testing is required for HIV-infected patients.

BMJ. 2013 Jul 31;347:f4841. doi: 10.1136/bmj.f4841. PubMed PMID: 23903456

Categories

CRS
Topics

Clinical Trials

A5327: Sofosbuvir + Ribavirin w/o Interferon for Treatment...

A5327 SWIFT-C is a Phase I, open-label, two-cohort clinical trial, in which between 44 and 50 acutely HCV-infected HIV-1...

Read More

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

Read More

A5279, Phase III Clinical Trial of Ultra-Short-Course...

This study will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active...

Read More

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate...

This study is currently on hold. The study is designed to characterize the pharmacokinetics of DLM using a model-based...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More