Because HIV patients achieved lower GMCs than HIV-uninfected persons, further studies evaluating the potential clinical implications of lower immune responses among this group are advocated. backward stepwise process was performed to derive the final model, maintaining piecewise linear terms for time after HAV vaccination throughout. All analyses were conducted using STATA version 10 and R version 2 (STATA Corporation; R Foundation for Statistical Computing, www.r-project.org). RESULTS Study Population Characteristics The study cohort consisted of 130 HIV-infected adults with a median age of 35 years (IQR, 30C41); 96% were male; and ethnicity was Caucasian for 51%, African American for 42%, and other for 7% (Table 1). The median body mass index (BMI) was 25.3 kg/m2, and 12% were classified as obese ( 30 kg/m2). Chronic hepatitis B and C were present among 9% and 2% of participants, respectively. At first dose of HAV vaccination, the median CD4 count was 461 cells/mm3 (IQR, 322C617 cells/mm3). Of the total participants, 49% had a plasma HIV RNA level 1000 copies/mL. Of the 62% who were receiving highly active antiretroviral therapy (HAART), 63% had an HIV RNA level 1000 copies/mL. The median CD4 nadir before vaccination was 309 cells/mm3 (IQR 192C431 cells/mm3) and 14% had a prior AIDS-defining condition. Table 1. Study Population Characteristics at Time of Hepatitis A Isobutyryl-L-carnitine Virus Vaccination = 130Participants with initial seropositive responsec= 116Participants without initial seropositive response = 14= 116]225.3 (23.7C28.2) [= 102]225.3 (23.9C26.2) [= 14]2????Obese (BMI 30 kg/m2)14 (12%) [= 116]212 (12%) [= 102]22 (14%) Isobutyryl-L-carnitine [= 14]2HAV vaccine factorsInterval between 2 doses of vaccine, d214 (183C306)214 (183C306)244 (183C297)HIV-specific factorsCurrentd CD4 cell count, cells/mm3461 (322?617)467 (344C630)322 (225C491)????Current CD4 cell count 200 cells/mm310 (8%)6 (5%)4 (29%)????Current CD4 cell count 200 to 350 cells/mm330 (23%)25 (22%)5 (36%)????Current CD4 cell count 350 cells/mm390 (69%)85 (73%)5 (36%)Plasma HIV RNA leveld 1000 copies/mL63 (49%) [= 129]258 (50%) [= 116]25 (38%) [= 13]2Currentd receipt of HAART, yes81 (62%)72 (62%)9 (64%)Nadir CD4 count, cells/mm3309 (192?431)312 (197C435)227 (174C416)????CD4 nadir 200 cells/mm333 (25%)29 (25%)4 (29%)History of AIDS-defining condition, yes18 (14%)16 (14%)2 (14%) Open in a separate window NOTE.?BMI, body mass index; HAV, hepatitis A virus; HIV, human immunodeficiency virus; HAART, highly active antiretroviral therapy. aCategorical variables are shown as numbers (percentages) and continuous values as medians (interquartile ranges). bAll data represent 130 total participants, except where otherwise noted due to missing data: 14 participants were missing BMI data due to lack of recorded weights within the database, and 1 participant was missing an HIV RNA level at time of vaccination. cUsed all results within 12 6 mo postvaccination. dCurrent was defined as the closest value at or prior to the first HAV vaccine administration. Antibody Responses to HAV Vaccination Initial positive vaccine seroresponses at 12 ( 6) months postvaccination were achieved in 89% (95% CI, 83%C94%) of HIV-infected persons. Among initial responders (= 116), 90% (95% CI, 83%C95%) maintained an HAV IgG level 10 mIU/mL at 3 years postvaccination. Finally, among participants with an initial protective antibody response Isobutyryl-L-carnitine who also had available specimens (= 74), 85% (95% CI, 75%C92%) continued to have a protective level at 6C10 years (median time 8.2 y; IQR, 7.1C8.8 y) postvaccination. We examined the seropositive responses at each of the 3 time points (1, 3, and 6C10 y postvaccination) stratified by the CD4 count at the first dose of HAV vaccination (Table 2). Participants who had a CD4 count 350 cells/mm3 at the time of HAV vaccine receipt had a significantly higher 1-year postvaccination seropositivity rate than those with a CD4 count 350 cells/mm3 at HAV vaccination (94% Rabbit Polyclonal to PPGB (Cleaved-Arg326) vs 78%, = .006). The seropositivity rate at 3 years postvaccination was also higher among those with more robust CD4 counts at initial vaccination (95% vs 87%), although this did not reach statistical significance (= .09). There were no significant differences between the seropositivity rates at 6C10 years by CD4 strata, although.