Table 3. Summary of Day 0 concentrations of soluble immune mediators and pH and comparison of changes in levels between TFV and placebo groups.
| Day 0 Tenofovir | Day 0 placebo | Group effect | Pvalue | |
| Median (IQR) | ||||
| Protein (µg/ml) | 230 (150–406) | 193 (125–404) | −0.25 | 0.05 |
| Lysozyme (ng/ml) | 95 (74–330) | 105 (79–654) | −0.18 | 0.32 |
| Lactoferrin (ng/ml) | 378 (136–609) | 526 (82–825) | −0.41 | 0.09 |
| SLPI (ng/ml) | 250 (122–337) | 124 (34–320) | −0.57 | 0.04 |
| IgA (µg/ml) | 2 (0.4–3) | 1 (0.4–2) | −0.15 | 0.51 |
| IgG (µg/ml) | 16 (7–34) | 12 (5–33) | −0.28 | 0.12 |
| HNP1-3 (ng/ml) | 29 (8–346) | 39 (10–576) | 0.21 | 0.64 |
| IFN-α2 (pg/ml) | 4 (2–8) | 4 (2–8) | −0.01 | 0.97 |
| IFN-γ (pg/ml) | 1 (0.6–1) | 1 (0.1–3) | −0.25 | 0.28 |
| IL-1α (pg/ml) | 28 (11–77) | 49 (22–95) | −0.62 | 0.02 |
| IL-1β (pg/ml) | 2 (1–4) | 3 (0.1–15) | −0.16 | 0.66 |
| IL-1ra (ng/ml) | 8 (6–12) | 7 (4–10) | −0.25 | 0.01 |
| IL-6 (pg/ml) | 12 (3–33) | 14 (2–19) | −0.22 | 0.56 |
| IL-8 (pg/ml) | 153 (73–2760) | 190 (90–869) | −0.64 | 0.03 |
| MIP-1α (pg/ml) | 9 (3–14) | 8 (5–18) | 0.48 | 0.06 |
| MIP-1β (pg/ml) | 5 (2–22) | 11 (4–20) | 0.36 | 0.22 |
| MIP-3α (pg/ml) | 54 (4–151) | 19 (12–77) | −0.86 | 0.16 |
| RANTES (pg/ml) | 3 (2–5) | 3 (2–5) | 0.18 | 0.55 |
| Estradiol (pg/ml) | 86 (38–120) | 54 (36–110) | 16.75 | 0.45 |
| Progesterone (ng/ml) | 0.3 (0.2–0.5) | 0.2 (0.2–0.3) | 0.77 | 0.54 |
| Mean (SD) | ||||
| Vaginal pH | 4.63 (0.5) | 4.66 (0.3) | 0.14 | 0.09 |
| CVL pH | 4.5 (0.3) | 4.59 (0.3) | 0.003 | 0.89 |
IQR, interquartile range; SD, standard deviation
Mediators were evaluated on Days 0, 3, 7, 14 and 21, except for MIP-3α (Days 0, 3 and 7), estradiol and progesterone (Days 0, 7 and 14). Some subjects were missing measurements, therefore the total number of observations was lower for these markers. 138 observations were available for all variables with the exception of IgG (n = 137), MIP-3α (n = 64), estradiol (n = 81), progesterone (n = 82), vaginal pH (n = 137), and CVL pH (n = 95). Variables were log-transformed, with the exception of estradiol, progesterone, vaginal pH, and CVL pH. Baseline immune mediator concentrations for both TFV and placebo subjects reflect substantial variability within subjects. Group effect represents the effect of TFV vs. placebo treatment on mediator levels, adjusted for study visit day. There was no statistically significant group effect for any mediator using a threshold of p-value <0.01.