Effect of aciclovir on lesional, seminal, cervical and plasma HIV-1 RNA among HIV-1 positive patients with HSV-2 infection, by treatment arm, seen at day 14 visit*
| Day 0† | Day 14† | Measure of effect‡ (95% CI) | |||||
| Placebo | Aciclovir | Placebo | Aciclovir | Unadjusted | Adjusted | p Value | |
| Lesional HIV-1 RNA detected among all, n/N (%) | 48/113 (42) | 53/117 (45) | 16/21 (76) | 10/15 (56) | RR=0.73 | RR=0.64 | 0.05 |
| (0.45 to 1.18) | (0.41 to 0.99) | ||||||
| Quantity of lesional HIV-1 RNA among patients with detectable lesional HIV-1 RNA, mean (95% CI), log10 copies/ml | 3.90 | 3.85 | 3.63 | 4.09 | Coeff 0.47 | Coeff 0.36 | 0.38 |
| (3.67 to 4.12) | (3.64 to 4.05) | (3.22 to 4.04) | (3.38 to 4.81) | (−0.25 to 1.18) | (−0.47 to 1.19) | ||
| Seminal HIV-1 RNA detected among men, n/N (%) | N/A | N/A | 24/30 (80.0) | 15/32 (46.9) | RR=0.59 | RR=0.59§ | 0.01 |
| (0.39 to 0.89) | (0.40 to 0.88) | ||||||
| Quantity of seminal HIV-1 RNA among men with detectable seminal HIV-1 RNA, mean (95% CI), log10 copies/ml | N/A | N/A | 4.14 | 3.97 | Coeff −0.17 | Coeff −0.14§ | 0.62 |
| (3.78 to 4.51) | (3.50 to 4.44) | (−0.74 to 0.40) | (−0.72 to 0.44) | ||||
| Cervical HIV-1 RNA detected among women¶, n/N (%) | 19/30 (63) | 22/37 (59) | 12/17 (71) | 7/25 (68) | RR=0.96 | RR=0.83 | 0.35 |
| (0.64 to 1.46) | (0.56 to 1.22) | ||||||
| Quantity of cervical HIV-1 RNA among women with detectable cervical HIV-1 RNA, mean (95% CI), log10 copies/ml | 3.54 | 3.48 | 3.64 | 3.62 | Coeff −0.02 | Coeff −0.08 | 0.77 |
| (3.24 to 3.85) | (3.23 to 3.72) | (3.30 to 3.99) | (3.19 to 4.05) | (−0.59 to 0.54) | (−0.66 to 0.50) | ||
| Plasma HIV-1 RNA among patients with detectable plasma HIV-1 RNA**, mean (95% CI), log10 copies/ml | 4.96 | 4.98 | 4.63 | 4.71 | Coeff 0.07 | Coeff 0.09 | 0.31 |
| (4.81 to 5.11) | (4.84 to 5.12) | (4.49 to 4.78) | (4.55 to 4.87) | (−0.13 to 0.29) | (−0.08 to 0.26) | ||
↵* Secondary end points at D14 visit included evaluation of lesional HIV-1 RNA, seminal HIV-1 RNA and cervical HIV-1 RNA and this D14 visit includes days 11–17; for plasma HIV-1 RNA, end-point measurement occurred at D28 visit, which included days 25–31.
↵† Data are the number of patients with finding/total number of patients evaluated (% of patients with finding).
↵‡ The RR was calculated by Poisson regression with robust standard errors, adjusted for baseline detection of virus except seminal plasma that had no baseline. Coeff. values were calculated by linear regression, with adjustment for viral load at baseline, except for seminal plasma, for which we used quantile regression without adjustment.
↵§ Adjusted for baseline plasma HIV viral load (log10 copies/ml).
↵¶ Data missing for eight women and four women in placebo and aciclovir groups, respectively, at D0 visit and 16 women and 10 women, respectively, at D14 visit out of which a total of 13 samples were not taken owing to menstruation on day of visit.
↵** Plasma HIV RNA was only measured at D0 and D28.
Coeff., difference of means (linear regression coefficient).