Placebo arm | Aciclovir arm | Measure of effect‡ | |
Healed/examined† | Healed/examined† | RR (95% CI) | |
All patients | 148/176 (84) | 152/178 (85) | 1.02 (0.93 to 1.11) |
Female | 41/46 (89) | 41/46 (89) | 1.00 (0.87 to 1.15) |
Male | 107/130 (82) | 111/132 (84) | 1.02 (0.92 to 1.14) |
HIV negative | 61/69 (88) | 61/70 (87) | 0.99 (0.87 to 1.12) |
HIV-1 positive | 87/107 (81) | 91/108 (84) | 1.04 (0.92 to 1.17) |
With CD4+ <200 cells/μl | 37/43 (86) | 34/42 (81) | 0.94 (0.77 to 1.14) |
With CD4+ ≥200 cells/μl | 46/56 (82) | 48/56 (86) | 1.04 (0.89 to 1.23) |
HIV-1-seropositive patients with HSV-2 ulcers | 66/78 (85) | 62/71 (87) | 1.03 (0.91 to 1.75) |
HIV-1-seropositive patients with HSV-2 infection | 84/102 (82) | 88/104(85) | 1.03 (0.91 to 1.16) |
Type of HSV-2 ulcers | |||
First episode HSV-2 | 28/34 (82) | 19/22 (86) | 1.05 (0.83 to 1.32) |
Recurrent HSV-2, HIV uninfected | 12/15 (80) | 18/19 (95) | 1.18 (0.90 to 1.56) |
Recurrent HSV-2, HIV-1 infected | 55/64 (86) | 53/62 (85) | 0.99 (0.86 to 1.15) |
Duration of ulcer at enrolment | |||
<1 week | 76/87 (87) | 80/86 (93) | 1.06 (0.96 to 1.18) |
≥1 week | 69/86 (80) | 69/89 (78) | 0.97 (0.83 to 1.13) |
↵* Primary end point at day 14 visit is for evaluation of ulcer healing and this visit includes days 11–17.
↵† A ≥90% reduction in size, compared with size at day 0. Data are the number of patients with healed ulcers /total number of patients examined (% of patients with healed ulcers).
↵‡ The RR was calculated by Poisson regression with robust standard errors.