Table 3. Impact of aciclovir on genital and plasma HIV-1 RNA, genital HSV-2 DNA, genital ulcer disease over follow-up visits (using Summary and Repeated measures analyses).
Aciclovir (N=146) |
Placebo (N=142) |
Measure of effect* (95%CI) |
p-value | |
---|---|---|---|---|
Summary measures analysis (per woman) | ||||
| ||||
HIV-1 RNA | ||||
| ||||
Women with genital HIV-1 RNA detected at least once |
101 (69%) | 102 (72%) | RR = 0.96 (0.83 to 1.12) | 0.62 |
| ||||
Women with genital HIV-1 RNA detected at: | ||||
No visit | 45 (31%) | 40 (28%) | ||
0% < visits < 50% | 34 (23%) | 24 (17%) | OR = 0.57 (0.36-0.89) | 0.013 |
50% ≤ visits < 100% | 34 (23%) | 36 (25%) | ||
All visits (100%) | 33 (23%) | 42 (30%) | ||
| ||||
Mean genital HIV-1 RNA (SD) among women with detectable HIV-1 RNA, log10 copies/mL |
2.92 (0.63) | 3.04 (0.65) | −0.13 (−0.28 to 0.03) | 0.12 |
| ||||
Mean plasma HIV-1 RNA (SD), log10 copies/mL |
3.67 (1.00) | 3.84 (0.97) | −0.27 (−0.41 to −0.13) | <0.001 |
| ||||
HSV-2 DNA | ||||
| ||||
Women with genital HSV-2 DNA detected at least once |
48 (33%) | 77 (54%) | RR = 0.61 (0.46 to 0.80) | <0.001 |
| ||||
Women with genital HSV-2 DNA detected at: | ||||
No visit | 98 (65%) | 65 (46%) | ||
0% < visits < 50% | 34 (23%) | 44 (31%) | OR = 0.40 (0.25 to 0.64) | <0.001 |
50% ≤ visits < 100% | 13 (9%) | 31 (22%) | ||
All visits (100%) | 1 (1%) | 2 (1%) | ||
| ||||
Mean genital HSV-2 DNA (SD) among women with detectable HSV-2 DNA, log10 copies/mL |
3.38 (1.44) | 3.81 (1.51) | −0.42 (−0.96 to 0.12) | 0.13 |
| ||||
Proportion of women with at least one GUD episode |
11 (8%) | 25 (18%) | RR = 0.43 (0.22 to 0.84) | 0.01 |
| ||||
Repeated measures analysis (per visit) | ||||
| ||||
HIV-1 RNA | Visits = 525 | Visits = 535 | ||
| ||||
Proportion of visits with detectable genital HIV- 1 RNA |
228 (43%) | 265 (50%) | RR = 0.88 (0.72 to 1.06) | 0.18 |
| ||||
HSV-2 DNA | Visits = 527 | Visits = 539 | ||
| ||||
Proportion of visits with detectable genital HSV-2 DNA |
60/527 (11%) | 113/539 (21%) | RR = 0.54 (0.39 to 0.74) | <0.001 |
Risk ratios, odds ratios or mean differences. Mean differences adjusted for baseline values and OR adjusted for baseline frequency of shedding
CI, confidence interval; GUD, genital ulcer disease; OR, odds-ratio; RR, risk ratio; SD, standard deviation.