Table 2.
Effect of Follicular Versus Luteal Phase on Study Endpoints
| FOL phase in S119 and S124 studies (n = 39) | LUT phase in S119 and S124 studies (n = 39) | |||||
|---|---|---|---|---|---|---|
| Variable (units) | Mean | SD | Mean | SD | Unadjusted p-value | Adjusted p-value* |
| Antimicrobial activity of the CVL (% Inhibition) | ||||||
| HSV-2 inhibition | 42.6 | 33.5 | 51 | 31.2 | .24 | .24 |
| E. coli inhibition | 18.2 | 43.3 | 32.4 | 45.1 | .32 | .12 |
| HIV inhibition | 17.6 | 49.3 | 14.3 | 48.3 | .99 | .76 |
| p24 antigen production from vaginal (S119) or ectocervical (S124) tissue biopsies (pg.ml × mg tissue) | ||||||
| p24_0 | 1.7 | 2.2 | 1.9 | 2.7 | .32 | .71 |
| p24_7 | 27.6 | 33.4 | 54.8 | 123 | .42 | .17 |
| p24_14 | 41.7 | 51.1 | 72.5 | 133.1 | .61 | .15 |
| p24_21 | 97 | 254.1 | 81.8 | 155.1 | .63 | .74 |
| p24_Soft | 83.4 | 241.9 | 79.6 | 154.2 | .87 | .94 |
| p24_Cum | 168.1 | 287.1 | 211 | 379.4 | .77 | .53 |
| p24_Max | 105.9 | 253.5 | 95.2 | 168.7 | .85 | .82 |
| p24_AUC | 831 | 1176.7 | 1183.8 | 2140.8 | .70 | .32 |
| Immune cell populations (cells/mm2) in the EPI and LP and vaginal tissue histology | ||||||
| Epithelial thickness (μm) | 273 | 102.4 | 312.8 | 112.4 | .14 | .08 |
| Number of cell layers | 24.5 | 6.5 | 26.7 | 7.5 | .42 | .07 |
| CD45 EPI | 120.8 | 60.5 | 95.5 | 41.7 | .63 | .07 |
| CD45 LP | 75 | 39.2 | 69.4 | 35 | .41 | .55 |
| CD3 EPI | 87.3 | 44.1 | 70.2 | 33.2 | .99 | .15 |
| CD3 LP | 47.1 | 29.6 | 46.4 | 26.7 | .41 | .91 |
| CD8 EPI | 59.7 | 33.1 | 49.8 | 25.2 | .99 | .12 |
| CD8 LP | 31.3 | 24.7 | 29.7 | 17.7 | .61 | .78 |
| CD4 EPI | 0 | 0 | 0.1 | 0.3 | .50 | .17 |
| CD4 LP | 2.3 | 4 | 2.2 | 3.5 | .65 | .93 |
| CCR5 EPI | 0 | 0 | 0 | 0.2 | .99 | .30 |
| CCR5 LP | 3.3 | 4.9 | 3.4 | 5 | .84 | .91 |
| HLADR EPI | 45 | 26 | 51.1 | 33.3 | .62 | .35 |
| HLADR LP | 36.1 | 24.5 | 41.5 | 23.3 | .50 | .27 |
| Vaginal microflora | ||||||
| Vaginal pH | 4.3 | 0.4 | 4.4 | 0.3 | .82 | .85 |
| Nugent score | 2.5 | 2.8 | 2.8 | 3.0 | .85 | .66 |
*
p-Value of visit adjusted for race, study, and contraceptive use/sexual practices.
AUC, area under the curve; CVL, cervicovaginal lavage; EPI, epithelium; HIV, human immunodeficiency virus; LP, lamina propria.