CD4 T CELL ASSESSMENTS IN EVALUATION OF HIV THERAPEUTICS - Flow Cytometry in Drug Discovery and Development - page 176

TABLE 8.4 ( Continued)

Clinical stage 3
Unexplained severe weight loss ( > 10% of presumed or measured body weight)
Unexplained chronic diarrhea for > 1 month
Unexplained persistent fever for > 1month ( > 37.6 C, intermittent or constant)
Persistent oral candidiasis (thrush)
Oral hairy leukoplakia
Pulmonary tuberculosis (current)
Severe presumed bacterial infections (e.g., pneumonia, empyema, pyomyositis, bone or joint
infection, meningitis, bacteremia)
Acute necrotizing ulcerative stomatitis, gingivitis, or periodontitis
Unexplained anemia (hemoglobin < 8 g/dL)
Neutropenia (neutrophils < 500 cells/ m L)
Chronic thrombocytopenia (platelets < 50,000 cells/ m L)
Clinical stage 4
HIV wasting syndrome, as defined by the CDC (see Table 8.3)
Pneumocystis pneumonia
Recurrent severe bacterial pneumonia
Chronic herpes simplex infection (orolabial, genital, or anorectal site for > 1month or
visceral herpes at any site)
Esophageal candidiasis (or candidiasis of trachea, bronchi, or lungs)
Extrapulmonary tuberculosis
Kaposi sarcoma
Cytomegalovirus infection (retinitis or infection of other organs)
Central nervous system toxoplasmosis
HIV encephalopathy
Cryptococcosis, extrapulmonary (including meningitis)
Disseminated nontuberculosis mycobacteria infection
Progressive multifocal leukoencephalopathy
Candida of the trachea, bronchi, or lungs
Chronic cryptosporidiosis (with diarrhea)
Chronic isosporiasis
Disseminated mycosis (e.g., histoplasmosis, coccidioidomycosis, penicilliosis)
Recurrent nontyphoidal Salmonella bacteremia
Lymphoma (cerebral or B cell non-Hodgkin)
Invasive cervical carcinoma
Atypical disseminated leishmaniasis
Symptomatic HIV-associated nephropathy
Symptomatic HIV-associated cardiomyopathy
Reactivation of American trypanosomiasis (meningoencephalitis or myocarditis)

Source: WHO case definitions of HIV for surveillance and revised clinical staging and immunological
classification of HIV-related disease in adults and children, August 7, 2006.

is also recommended to use successive counts to determine when to initiate ARV
rather than one count that could have a higher degree of variability due to technical
bias or biological reasons [34, 35]. The frequency of counts also plays a role in
accuracy [34].