Table 2.

Primary efficacy outcome: HIV-1 incidence in the primary and secondary efficacy analyses

	End of study		Censored at 2% PRO2000 gel discontinuation, Feb 14, 2008
	0·5% PRO2000 (n=3326)	Placebo (n=3325)	2% PRO2000 (n=2734)	0·5% PRO2000 (n=2732)	Placebo (n=2722)
Primary efficacy analysis*
Participants	3156	3112	2591	2587	2543
Woman-years of follow-up	2873	2836	1741	1732	1717
Seroconversions	130	123	82	67	67
Incidence†	4·5 (3·8–5·4)	4·3 (3·6–5·2)	4·7 (3·8–5·8)	3·9 (3·0–4·9)	3·9 (3·1–5·0)
Hazard ratio	1·05 (0·82–1·34)	1	1·21 (0·88–1·68)	0·99 (0·70–1·39)	1
p value	0·71	..	0·24	0·94	..
Second efficacy analysis‡
Participants	3156	3112	2591	2587	2543
Woman-years of follow-up	3133	3099	1847	1846	1832
Seroconversions	145	143	86	70	77
Incidence†	4·6 (3·9–5·4)	4·6 (3·9–5·4)	4·7 (3·8–5·8)	3·8 (3·0–4·8)	4·2 (3·4–5·3)
Hazard ratio	1·00 (0·79–1·26)	1	1·11 (0·82–1·51)	0·90 (0·65–1·24)	1
p value	0·99	..	0·50	0·53	..

Data are n or n (95% CI) unless otherwise stated. ..=not applicable.

^*All enrolled participants, excluding those with HIV-1 infection at enrolment, those without follow-up data for HIV-1 infection, and censored at 52 weeks (plus 6 week window for final visit) or pregnancy.

^‡Equivalent to primary efficacy analysis, but not censored for pregnancy or at week 52.

^†Per 100 woman-years.