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Table 1 Characteristics of the 18 non-inferiority studies

From: Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

 

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)

  1. *one-sided 5% type I error
  2. ** one-sided 1.25% type I error
  3. 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