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Background Patients with HIV and low CD4 counts starting antiretroviral therapy (ART) are at high risk for immune reconstitution inflammatory syndrome (IRIS) and death. Methods To investigate the clinical impact of IRIS in adults with HIV and CD4 counts below 100 cells/µL starting ART, we designed an international, prospective, observational study in United States, Thailand, and Kenya. An independent review committee adjudicated IRIS events. We used Cox models to investigate associations between baseline biomarkers, IRIS, immune recovery at week 48, and death by week 48. Results We enrolled 506 participants, 39.3% of whom were women. Median age was 37 years (IQR 31-45) and CD4 T cell count was 29 cells/µL (IQR 11-56). Within 6 months of ART initiation, 97 (19.2%) participants developed IRIS and 31 (6.5%) died. Participants with lower hemoglobin at study start were at higher risk of IRIS (HR 1.2, p=0.004). IRIS was independently associated with increased risk of death even after adjustment for known risk factors (HR 3.2, P=0.031). In addition, being female (P=0.004), having lower BMI (P=0.003), higher WBC (P=0.005) and higher D-dimer levels (P=0.044) were also significantly associated with increased risk of death. Decision tree analysis identified hemoglobin less than 8.5 g/dL as highly predictive of IRIS and CRP>106 µg/ml and BMI < 15.6 kg/m2 as predictive of death . Conclusions For patients with HIV and severe immunosuppression who are initiating ART, baseline low BMI and hemoglobin, and high CRP and D-dimer may be clinically useful predictors of IRIS and death risk.

To determine the etiology of bloodstream infections (BSIs) in hospitalized patients >/=15 years old in Thailand, prospectively enrolled, consecutive febrile (>/=38 degrees C) patients were admitted to one hospital during February-April 1997. After a patient history was taken and a physical examination was performed, blood was obtained for comprehensive culture and human immunodeficiency virus (HIV) testing. Of 246 study patients, 119 (48%) had BSIs, and 182 (74%) were infected with HIV. The 2 most common pathogens were Cryptococcus neoformans and Mycobacterium tuberculosis (30 and 27 patients, respectively). HIV-positive patients were more likely than HIV-negative patients to have mycobacteremia (57/182 vs. 0/64, P<. 0001), fungemia (38/182 vs. 2/64, P<.001), or polymicrobial BSIs (19/182 vs. 0/64, P<.002). Clinical predictors of BSIs included HIV infection, chronic diarrhea, lymphadenopathy, or splenomegaly. Mortality was higher among patients with than those without BSIs (P<. 001). Cohort-based microbiologic studies are critically important to diagnose emerging pathogens and to develop algorithms for empirical treatment of BSIs in developing countries.