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Table 2 Trade-off between increased woman-years (power) and falling adherence.

From: Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention

Scenario

Week

Adherence

Observed reduction

in HIV incidence*

95% CI

% power

1. Adherence is unchanged from

Week 40 to week 52

40

80%

40%

(17%, 56%)

85%

 

52

80%

40%

(20%, 55%)

90%

 

40

80%

35%

(11%, 52%)

72%

 

52

80%

35%

(14%, 51%)

80%

 

40

80%

30%

(6%, 48%)

55%

 

52

80%

30%

(8%, 47%)

64%

2. Adherence drops to 50% at week 52

40

80%

40%

(17%, 56%)

85%

 

52

50%

37%

(16%, 53%)

86%

 

40

80%

35%

(11%, 53%)

72%

 

52

50%

33%

(12%, 49%)

75%

 

40

80%

30%

(6%, 48%)

55%

 

52

50%

29%

(8%, 46%)

66%

3. Adherence drops to 0% at week 52

40

80%

40%

(17%, 56%)

85%

 

52

0%

34%

(14%, 50%)

79%

 

40

80%

35%

(11%, 52%)

72%

 

52

0%

29%

(6%, 45%)

63%

 

40

80%

30%

(6%,48%)

55%

 

52

0%

25%

(2%, 42%)

50%

  1. *Compared to placebo
  2. All figures are based on following assumptions:4% HIV incidence in control arm; 85% retention at week 40; 80% retention at week 52