Fig 1.
Treatment strategy.
Fig 2.
The vertical axis, (Z), is the number of observed treatment successes minus the number of expected successes. The higher the value represented on that vertical axis, the more favorable (better efficacy observed). The horizontal axis (V) is proportional to the number of patients who, over time, have been evaluated at day 29. Hence, over time, each arm’s data points extend to the right. Each arm starts inside the triangle (green area) and recruitment is stopped on crossing either the upper (blue area) or the lower boundary (pink area). Recruitment to the AmBisome monotherapy arm was stopped after the first interim analysis (I1) and to the combination arm after the second interim analysis (I2). Also shown are the final results for each arm, including those who had not reached the primary endpoint (day29) when the interim analysis was performed and the recruitment was stopped. These final results take the trajectory of each arm well away from the triangular boundary, which is known as ‘over-run'. The two numbers after each label are the numbers of patients included in that analysis and the number of these with treatment success at day 29.
Fig 3.
Trial participant flow.
Table 1.
Baseline characteristics.
Table 2.
HIV parameters and antiretroviral (ART) regimen at baseline.
Table 3.
Efficacy (as per sequential analysis).
Table 4.
Safety during the treatment phase.
Table 5.
Incidence of ADRs due to AmBisome or miltefosine.
Incidence>10% indicated in bold.
Table 6.
Serious adverse events.
Fig 4.
CD4-cell counts at baseline (D0), D29 and D58.
Categories are Cat 1 = <50, Cat 2 = 50–99, Cat 3 = 100–199, Cat 4 = 200–349, Cat 5 = ≥350 cells/μl. (A) AmBisome monotherapy arm (B) AmBisome+miltefosine combination arm.