O predict the probability of having detectable drug and the probability that the level of tenofovir diphosphate (TFV-DP) in PBMCs was .16 fmol per million viable cells, the concentration associated with an estimated 90 reduction in HIV acquisition. [15] Drug levels were multiply imputed [16] for visits at which drug level testing was not conducted but the participant was still taking study drug,
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
D if the HSV-2 diagnosis occurred at or after HIV seroconversion, and ulcers were excluded if they occurred at or after HIV seroconversion. We estimated the proportion of participants with 1 ulcer AE classified as Gradeor above (i.e., moderate, severe, or potentially life-threatening), 1 STI examination during which a perianal ulcer was detected, and 1 STI examination during which a groin ulcer
T among participants living in Peru (46.0 ), Brazil (37.8 ), and Ecuador (37.3 ), with lower prevalence among participants living in Thailand (6.4 ), South Africa (17.6 ), and the United States (27.1 ; P,0.001). Randomization group was not associated with HSV-2 prevalence at baseline (P = 0.44). In multivariable analysis, all factors remained significantly associated with HSV-2 prevalence with the
Version; however, this finding was not confirmed by ulcers identified during STI examinations and may have included ulcers of nonherpetic etiologies. In contrast to the 51 reduction in HSV-2 incidence among women randomized to use a 1 tenofovir topical gel in CAPRISA 004, [9] our results suggest that tenofovir in daily oral FTC/TDF may reduce the occurrence of ulcers in individuals with HSV-2 in
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
No differences by randomization group in the proportion of participants with 1 STI examination during which a perianal ulcer (FTC/TDF 3.5 vs. placebo 4.7 , P = 0.37) or groin ulcer (FTC/TDF 2.5 vs. placebo 1.9 , P = 0.51) was identified; results were similar after excluding participants with a positive syphilis rapid plasma reagin test at the same visit. However, symptoms that prompted STI exam