Romanowski B, Aoki F Y, Martel A Y, Lavender E A, Parsons J E, Saltzman R L
Medical Microbiology and Immunology, Edmonton, Alberta, Canada.
AIDS. 2000 Jun 16;14(9):1211-7. doi: 10.1097/00002030-200006160-00019.
To compare the efficacy and safety of 7 days' treatment with famciclovir 500 mg twice a day versus acyclovir 400 mg five times a day, for mucocutaneous herpes simplex virus (HSV) infection in HIV-infected individuals.
Randomized, double-blind, parallel-group study to demonstrate equivalence for the primary efficacy parameter.
Forty-eight hospital-based or specialist public-health clinics in 12 countries.
Two-hundred and ninety-three HIV-positive patients with recurrent HSV infection (orolabial or genital) starting treatment within 48 h of first appearance of herpetic lesions.
Proportion of patients developing new lesions during treatment (primary outcome measures); Time to complete healing of lesions, time to cessation of viral shedding, time to loss of lesion-associated symptoms, number of withdrawals due to treatment failure (secondary outcome measures).
Equivalence was defined prospectively and famciclovir was equivalent to acyclovir in preventing new lesion formation: new lesions occurred in 16.7% and 13.3% of patients, respectively [difference, 3.4%; 95% confidence interval (CI), -4.8-11.5]. The groups were comparable in time to complete healing (median 7 days for both groups; hazard ratio, 1.01; 95% CI, 0.79-1.29; P = 0.95), cessation of viral shedding (median of 2 days [hazard ratio = 0.93; 95% C.I. 0.68, 1.27; p = 0.64]), and loss of lesion-associated symptoms (median 4 days; hazard ratio, 0.99; 95% CI, 0.75-1.30; P = 0.93). Similar numbers in each group withdrew because of treatment failure. There were no differences between groups in the incidence of adverse events.
Famciclovir given twice a day is as effective and well tolerated as high-dose acyclovir for mucocutaneous HSV infections in HIV-infected individuals, and has the convenience of less frequent dosing.
比较每天两次服用500毫克泛昔洛韦与每天五次服用400毫克阿昔洛韦，对HIV感染者黏膜皮肤单纯疱疹病毒（HSV）感染进行7天治疗的疗效和安全性。
随机、双盲、平行组研究，以证明主要疗效参数的等效性。
12个国家的48家医院或专科公共卫生诊所。
293例HIV阳性且复发性HSV感染（唇疱疹或生殖器疱疹）的患者，在疱疹性损害首次出现后48小时内开始治疗。
治疗期间出现新损害的患者比例（主要观察指标）；损害完全愈合时间、病毒脱落停止时间、损害相关症状消失时间、因治疗失败而退出研究的人数（次要观察指标）。
预先定义了等效性，泛昔洛韦在预防新损害形成方面与阿昔洛韦等效：分别有16.7%和13.3%的患者出现新损害[差异为3.4%；95%置信区间（CI），-4.8-11.5]。两组在完全愈合时间（两组中位数均为7天；风险比，1.01；95%CI，0.79-1.29；P = 0.95）、病毒脱落停止时间（中位数为2天[风险比 = 0.93；95%CI 0.68，1.
