Dorothy Sawo, FNP, PhD, and Madeline Torres, RN, Columbia University HPTR (Site 30329) CTU Grant 5U01 AI069470-01; GCRC Grant 5 UL1 RR021456-07. in stratum A was found to be ineligible after enrollment; 2 participants in stratum A and 1 participant in stratum C were not able to start vaccination series within 72 hours of entry and were removed from the study and excluded from the analysis. Therefore, CKLF the total number of participants in this analysis was 315, with 127 in stratum A, 95 in stratum B, and 93 in stratum C. Baseline participant characteristics are shown in Table ?Table1.1. Baseline seropositivity for each of the 4 HPV vaccine types is usually presented in Table ?Table2.2. It ranged between 13% and 45%; only 4% of women were seropositive for all those 4 types, with no difference among women with high or low baseline CD4 counts. We did L-Thyroxine not find an association between age and baseline seropositivity except for HPV type 18 in the highest and lowest CD4 strata (= .041 and .027, respectively). There were no statistically significant differences in seroprevalences in the US sites and non-US sites across the 3 CD4 strata. Cervical and/or anal HPV DNA results on types 6/11 (combined), 16, and 18 were available for 287 subjects (115 in CD4 stratum A, 86 each in B and C). Of the 146 subjects who were seronegative for types 6/11 at baseline, 2 (1.4%) were DNA positive. Of the 175 who were seronegative for type 16 at baseline, 14 (8.6%) were DNA positive, and of the 209 such subjects for type 18, 14 (6.7%) were DNA positive (data not shown). Table 1. Baseline Characteristics = .080) and compared with stratum B (92% vs 98%, = .096). Seroconversion proportions were too high for HPV types 6, 11, and 16 in strata A and B to discern differences between HIV RNA groups. In stratum C, seroconversion proportion for HPV types 6, 11, 16, and 18 were 89%, L-Thyroxine 97%, 100%, and 91%, respectively, among women with a viral load 400 copies/mL compared with 73%, 77%, 81%, and 56% among women with a viral load 400 copies/mL (= .29, .01, .01, and .001, respectively). Comparable results were found for all types using the viral cutoff of 10 000 copies/mL except for HPV-16, for which the result was only statistically significant when using the viral cutoff of 400 copies/mL. In the GEE model, the odds of seroconversion in HPV types 6, 11, and 16 were higher compared with type 18, with corresponding OR estimates of 3.45, 3.45, and 4.53 for types 6, 11, and 16 (= .0005, .0001, and .0001, respectively). The GEE model also showed that seroconversion was higher with CD4 cell count 200 L (odds ratio [OR], 3.31; = .01) and lower with HIV RNA 10 000 copies/mL (OR, 0.26; = .005). Age effect was not statistically significant. Safety Issues There were no significant safety issues identified by the study monitoring committee. There were 2 L-Thyroxine deaths, both from stratum A (1 from lymphoma and 1 from meningitis), neither related to the vaccine. One participant in stratum B had an allergic reaction; 1 participant from stratum C developed a grade 3 fever. Sixteen participants had grade 1 or higher fever reported during the postvaccination follow-up (n = 5, 4, and 7 in strata A, B, and C, respectively). Three participants from stratum C experienced grade 2 injection site reactions. Overall, 17% of.