Table 2.
HIV-1 endpoints and treatment effects on HIV-1 p24 replication from paired ectocervical and vaginal tissue.
| Endpoint p24 measure (Log10) | Least square mean (SE)
|
Probability | |
|---|---|---|---|
| Ectocervical (N=41) | Vaginal (N=41) | ||
| Cumulative (pg/ml) | 4.1 (.34) | 3.63 (.34) | .0011 |
| Cumulative (pg/mg) | 3.14 (.42) | 2.4 (.42) | <.0001 |
| Soft (pg/ml) | 3.67 (.41) | 3.21 (.41) | .0049 |
| Soft (pg/mg) | 2.76 (.46) | 2 (.46) | <.0001 |
| Ectocervical tissue (N=14) | Chlorhexidine
|
||
|---|---|---|---|
| (−) | (+) | ||
| Cumulative (pg/ml) | 4.27 (.43) | 4.05 (.43) | ns |
| Cumulative (pg/mg) | 3.36 (.43) | 3.32 (.43) | ns |
| Soft (pg/ml) | 3.94 (.43) | 3.65 (.43) | ns |
| Soft (pg/mg) | 3.04 (.44) | 2.92 (.43) | ns |
|
| |||
| Lidocaine
|
|||
| (−) | (+) | ||
|
| |||
| Cumulative (pg/ml) | 4.63 (.65) | 4.14 (.65) | ns |
| Cumulative (pg/mg) | 3.71 (.76) | 3.32 (.76) | ns |
| Soft (pg/ml) | 4.12 (.71) | 3.63 (.71) | ns |
| Soft (pg/mg) | 3.22 (.83) | 2.89 (.84) | ns |
| Vaginal tissue (N=14) | Chlorhexidine
|
||
|---|---|---|---|
| (−) | (+) | ||
| Cumulative (pg/ml) | 3.93 (.22) | 4.18 (.22) | ns |
| Cumulative (pg/mg) | 2.67 (.24) | 3.11 (.24) | .0058 |
| Soft (pg/ml) | 3.6 (.24) | 3.75 (.24) | ns |
| Soft (pg/mg) | 2.33 (.24) | 2.7 (.24) | .0196 |
|
| |||
| Lidocaine
|
|||
| (−) | (+) | ||
|
| |||
| Cumulative (pg/ml) | 3.87 (.28) | 4.04 (.28) | ns |
| Cumulative (pg/mg) | 2.79 (.41) | 2.95 (.41) | ns |
| Soft (pg/ml) | 3.36 (.32) | 3.53 (.32) | ns |
| Soft (pg/mg) | 2.29 (.45) | 2.45 (.44) | ns |
SE, standard error; ns, not significant; −/+, without or with treatment prior to biopsy collection.
Weight-adjusted (pg/mg) and non-weight adjusted (pg/ml) p24 measurements were summed across test days 4 through 21 to provide cumulative p24 pg/mg and cumulative p24 pg/ml endpoints. The soft endpoint was calculated for weight-adjusted and non-weight adjusted p24 endpoints. Cumulative and soft p24 endpoints (pg/ml and pg/mg) were log10 transformed prior to analyses. A randomized block design ANOVA (PROC MIXED) was used to compare the log transformed virus growth measurements for paired ectocervical vs. vaginal biopsy challenge results, and at each biopsy location; ±lidocaine or ±chlorhexidine.