Table 1

Characteristics of the 18 non-inferiority studies


Power (%)
Double blind
Experimental arm(s) (ITT sample size)
Control arm (ITT sample size)

CNAAB3005 [10]
NA
Yes
ABA (262)
PI-based regimen (265)
NEFA [11]
90
No
(a) NVP BID (155)
EFV QD (156)



(b) ABA BID (149)

BEST [12]
90
No
IDV/RITO BID (162)
IDV TID (161)
2NN [13]
80
No
(a) NVP QD (220)
EFV (400)



(b) NVP BID (387)




(c) NVP+EFV (209)

903 [14]
80
Yes
TNF (299)
Stavudine (301)
SOLO [15]
85
No
FPV/RITO QD (322)
Nelfinavir BID (327)
FTC-303 [16]
85
No
FTC QD (294)
3TC BID (146)
EPV20001 [17]
80
Yes
3TC QD (278)
3TC BID (276)
ALIZE [18]
80
No
FTC-ddI-EFV QD (178)
PI-based regimen BID/TID (177)
CNA30024 [19]
85
Yes
ABA BID (324)
AZT BID(325)
BMS-2004 [20]
90
Yes
Atazanavir (405)
EFV (405)
ESS40013 [21]
80
No
Stop EFV (141)
Continue EFV (141)
SEAL [22]
80
No
3TC+ABA QD (130)
3TC+ABA BID (130)
BMS-045 [23]
NA
No
(a) ATA/RITO QD (120)
LOPI/RITO BID (123)



(b) ATA/SAQUI (115)

CNA30021 [24]
90
Yes
ABA QD (384)
ABA BID (386)
CONTEXT [25]
NA
No
(a) FPV/RITO QD (105)
LOPI/RITO BID (103)



(b) FPV/RITO BID (107)

SHAART [26]
80
No
ABA BID (68)
NVP BID (66)
934 [27]
85
No
TNF+FTC QD (255)
AZT+3TC BID (259)

*one-sided 5% type I error

** one-sided 1.25% type I error

Abbreviations : NA: not available; E: equivalence; NI: non-inferiority; ABA: abacavir PI: protease inhibitor ; NVP: nevirapine ; EFV: efavirenz ; IDV: indinavir ; RITO: ritonavir ; TNF : tenofovir ; FPV: fosamprenavir; FTC : emtricitabine; 3TC: lamivudine ; ddI: didanosine ; AZT : zidovudine ; QD: once-a-day ; BID: twice-a-day ; TID three times-a-day

Parienti et al. BMC Medical Research Methodology 2006 6:46   doi:10.1186/1471-2288-6-46