Table 5.
The impact of acyclovir on plasma HIV-1 RNA & CD4 count, by treatment arm (modified intention to treat analysis)
| Acyclovir | Placebo | Unadjusted regression coefficient (95%CI) |
Adjusted regression coefficient (95%CI)1 |
P-value2 | |
|---|---|---|---|---|---|
| Plasma HIV-1 RNA load (log copies/ml) | |||||
| Mean (SE) | Mean (SE) | ||||
| 6 months | (N=210) | (N=189) | 0.04 (−0.16, 0.24) |
0.043 (−0.07, 0.15) |
0.49 |
| 4.32 (0.07) | 4.28 (0.08) | ||||
| 12 months | (N=192) | (N=170) | 0.05 (−0.16, 0.27) |
0.03 (−0.11, 0.16) |
0.69 |
| 4.26 (0.07) | 4.21 (0.08) | ||||
| 24 months | (N=117) | (N=102) | 0.05 (−0.23, 0.33) |
−0.04 (−0.23, 0.15) |
0.69 |
| 4.48 (0.09) | 4.43(0.11) | ||||
| Repeated measures analysis (6, 12 and 24 months) | |||||
|
All samples |
(N=519)5 | (N=461)6 | 0.07 (−0.18, 0.20) |
0.02 (−0.09, 0.13) |
0.69 |
| 4.33 (0.07) | 4.29 (0.07) | ||||
|
≥ 90% adherence |
(N=293)7 | (N=244)8 | −0.01 (−0.23, 0.21) |
−0.02 (−0.15, 0.10) |
0.72 |
| 4.29 (0.08) | 4.31 (0.08) | ||||
|
<90% / unknown adherence |
(N=226)9 | (N=217)10 | 0.06 (−0.19, 0.30) |
0.09 (−0.05, 0.23) |
0.23 |
| 4.40 (0.08) | 4.26 (0.10) | ||||
| CD4 count (cells/μl) | |||||
|
Geometric mean (95%CI) |
Geometric mean (95%CI) |
||||
| All women | (N=181)11 | (N=151)12 | 0.11 (0.03, 0.19) 13 |
0.009 | |
| 346 (313, 381) | 271 (237, 310) | ||||
|
≥ 90% adherence |
(N=93)14 | (N=94)15 | 0.13 (0.03, 0.23) 13 |
0.008 | |
| 355 (309, 407) | 263 (223, 311) | ||||
|
<90% / unknown adherence |
(N=88)16 | (N=57)17 | 0.07 (−0.04, 0.19) 13 |
0.22 | |
| 336 (291, 388) | 284 (227, 357) | ||||
1
Adjusted for baseline plasma HIV RNA load (log10 copies/ml)
2
For primary measure of effect – adjusted regression coefficient
3
Adjusted measure of effect excludes one women in the acyclovir arm who has no baseline PVL measurement
5
519 visits in 218 women
6
461 visits in 201 women
7
293 visits in 169 women
8
244 visits in 143 women
9
226 visits in 147 women
10
217 visits in 140 women
11
181 visits in 131 women
12
151 visits in 112 women
13
regression coefficient for log CD4 count
14
93 visits in 78 women
15
94 visits in 72 women
16
88 visits in 82 women
17
57 visits in 55 women.