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

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

Read More

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

A5288: MULTIOCTAVE, Management Using the Latest Technologies...

The study is being done to: test a strategy of using a resistance test to choose anti-HIV drugs. Resistance tests look at the...

Read More

A5207, Maintaining Options for Mothers Study (MOMS): A Phase...

A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to...

Read More

HPTN 078: Enhancing Recruitment, Linkage to Care and...

The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable...

Read More