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Table 5 Presumptive and definitive criteria for AIDS-defining events

From: CryptoDex: A randomised, double-blind, placebo-controlled phase III trial of adjunctive dexamethasone in HIV-infected adults with cryptococcal meningitis: study protocol for a randomised control trial

 

Presumptive criteria

Definitive criteria

Constitutional disease

  

HIV wasting syndrome

Unexplained involuntary weight loss >10% from baseline PLUS persistent diarrhoea with ≥2 liquid stools/day for >1 month OR chronic weakness OR persistent fever >1 month. Should exclude other causes such as cancer, TB, MAC, cryptosporidiosis or other specific enteritis

 

Infections

  

Aspergillosis, other invasive

CXR abnormality compatible with aspergillosis PLUS invasive mycelia consistent with Aspergillus on lung biopsy or positive culture of lung tissue or positive culture of sputum

CXR abnormality compatible with aspergillosis PLUS invasive mycelia consistent with Aspergillus on lung biopsy PLUS positive culture of lung tissue or positive culture of sputum

Bartonellosis

Clinical evidence of bacillary angiomatosis or bacillary peliosis PLUS positive silver stain for bacilli from skin lesion or affected organ

Clinical evidence of bacillary angiomatosis or bacillary peliosis PLUS positive culture or PCR for Bartonella quintana or Bartonella henselae

Candidiasis of bronchi, trachea or lungs

None

Macroscopic appearance at bronchoscopy or histology or cytology (not culture)

Candidiasis, oesophageal

Recent onset retrosternal pain on swallowing PLUS clinical diagnosis or oral candidiasis by cytology (not culture) PLUS clinical response to treatment

Macroscopic appearance at endoscopy or histology or cytology (not culture)

Coccidiodomycosis, disseminated or extrapulmonary

None

Histology or cytology, culture or antigen detection from affected tissue

Cryptococcosis, meningitis or pulmonary

None

Histology or cytology/microscopy, culture or antigen detection from affected tissue

Cryptosporidiosis

None

Persistent diarrhoea >1 month, histology or microscopy

CMV retinitis

Typical appearance on fundoscopy of discrete patches of retinal whitening, associated with vasculitis, haemorrhage, and necrosis, confirmed by ophthalmologist

None

CMV end-organ disease

None

Compatible symptoms plus histology or detection of antigen from affected tissue

Infections

Presumptive criteria

Definitive criteria

CMV radiculomyelitis

Leg weakness and decreased reflexes or syndrome consistent with cord lesion presenting subacutely over days to weeks. CT/MRI shows no mass lesion. CSF shows >5 WBC with >50% polymorphs and positive CMV PCR, antigen or culture

None

CMV meningoencephalitis

Rapid (days to <4 weeks) syndrome with progressive delirium, cognitive impairment, ± seizures and fever (often with CMV disease elsewhere) CT/MRI may show periventricular abnormalities.

Rapid (days to <4 weeks) syndrome with progressive delirium, cognitive impairment, ± seizures and fever (often with CMV disease elsewhere) CT/MRI may show periventricular abnormalities and CSF PCR positive for CMV

HSV mucocutaneous ulceration

None

Persistent ulceration for >1 month, plus histology or culture or detection of antigen or HSV PCR positive from affected tissue

HSV visceral disease (for example, oesophagitis, pneumonitis

None

Symptoms, plus histology or culture or detection of antigen or HSV PCR positive from affected tissue

VZV multidermatomal

≥10 typical ulcerated lesions affecting at least two noncontiguous dermatomes plus response to an antiviral active against VZV unless resistance is demonstrated

≥10 typical ulcerated lesions affecting at least two noncontiguous dermatomes plus culture or detection of antigen or VZV PCR-positive from affected tissue

Histoplasmosis, disseminated or extrapulmonary

None

Symptoms plus histology or culture or detection of antigen from affected tissues

Isosporiasis

None

Persistent diarrhoea for >1 month, histology or microscopy

Leishmaniasis, visceral

None

Symptoms plus histology

Microsporidiosis

None

Persistent diarrhoea for >1 month, histology or microscopy

MAC, and other atypical mycobacteriosis

Symptoms of fever, fatigue, anaemia or diarrhoea plus acid-fast bacilli seen in stool, blood, body fluid, or tissue but not grown on culture and no concurrent diagnosis of TB except pulmonary

Symptoms of fever, fatigue, anaemia or diarrhoea plus culture from stool, blood, body fluid, or tissue

Tuberculosis, pulmonary

Symptoms of fever, dyspnoea, cough, weight loss, fatigue plus acid-fast bacilli seen in sputum, lavage, or lung tissue, not grown in culture, plus responds to standard TB treatment

Symptoms of fever, dyspnoea, cough, weight loss, fatigue plus positive TB culture or PCR from sputum, bronchial lavage, or lung tissue

Tuberculosis, extrapulmonary

Symptoms, plus acid-fast bacilli seen from affected tissue or blood but not grown in culture, concurrent diagnosis of pulmonary TB or responds to standard TB treatment

Symptoms, plus positive TB culture or PCR from affected tissue

Nocardiosis

Clinical evidence of invasive infection plus microscopic evidence of branching, Gram-positive, weakly acid-fast bacilli from affected tissue

Clinical evidence of invasive infection plus positive culture from blood or affected tissue

Penicillium marneffei disseminated

Characteristic skin lesions plus response to antifungal therapy for penicilliosis (in an endemic area)

Culture from a nonpulmonary site

Pneumocystis pneumonia (PCP)

Symptoms, any CXR appearance and CD4 count <200, negative bronchoscopy if treated for PCP for >7 days, no bacterial pathogens in sputum, and responds to PCP treatment

Microscopy or histology

Extrapulmonary pneumocystis

None

Symptoms plus microscopy or histology

Recurrent bacterial pneumonia

Second pneumonic episode within 1 year, new CXR appearance, symptoms and signs, diagnosed by a doctor

Second pneumonic episode within 1 year, new CXR appearance, detection of a pathogen

Progressive multifocal leukoencephalopathy (PML)

Symptoms and brain scan consistent with PML and no response to treatment for toxoplasmosis

Symptoms and brain scan consistent with PML and positive JC virus PCR in CSF or histology

Rhodococcus equi disease

None

Clinical evidence of invasive infection plus culture of organism from blood or affected tissue

Recurrent Salmonella septicaemia

None

Second distinct episode, culture confirmed

Cerebral toxoplasmosis

Symptoms of focal intracranial abnormality or decreased consciousness, and brain scan consistent with lesion(s) having mass effect or enhancing with contrast, and either positive toxoplasma serology or response to treatment clinically and by scan

Histology or microscopy

Extra-cerebral toxoplasmosis

None

Symptoms plus histology or microscopy

Neoplasms

  

Kaposi sarcoma (KS)

Typical appearance without resolution. Diagnosis should be made by an experienced HIV clinician

Histology

Cervical carcinoma, invasive

None

Histology

Lymphoma, primary cerebral

Symptoms consistent with lymphoma, at least one lesion with mass effect on brain scan, no response to toxoplasma treatment clinically and by scan

Histology

Lymphoma, non-Hodgkin B cell

None

Histology

lymphoma, Hodgkin

None

Histology

Neurologic

  

HIV encephalopathy

Cognitive or motor function interfering with usual activity, progressive over weeks or months in the absence of another condition to explain the findings. Should have a brain scan ± CSF examination to exclude other causes.

None

Other

  

Indeterminate cerebral lesion (s)

Neurologic illness, with evidence for an intracerebral lesion by brain scan, where the differential diagnosis is either cerebral toxoplasmosis. PML, cerebral lymphoma, or HIV encephalopathy

 
  1. Based on 1993 Revised CDC classification system (MMWR 1992; 41(RR-17): 1-19) and modified for this trial.