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
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,
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
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,
Cell counts (Fig. 1a) and CD4 : CD8 T cell ratio (Fig. 1a), but not correlated with viral load (Fig. 1c). Positive correlation was observed between sCD40L plasma levels and T cell immune activation defined by co-expression of CD38/HLA-DR on CD4 and CD8 T cells (Fig. 1d,e), as well as IDO-mRNA expression in ARTnaive patients ([7] and Fig. 1f). However, no correlation was observed between sCD40L and
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
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
Nversion to determine whether there were differences in ulcer occurrence by randomization group in the absence of study drug. All analyses were conducted in SAS 9.3 or Stata 12.Results Study participantsCharacteristics of the 2,499 iPrEx participants have been described previously. [13] Briefly, all participants were born male and 313 (13.0 ) identified as transgender or as women. The mean age at