Table 2 |
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|
Treatment Groups in Patients with Cutaneous Leishmaniasis (Brazil) |
||||
|
Cohort |
N |
Treatment |
Timing of Treatment |
|
|
|
||||
|
Study Injections |
Pentavalent Antimony (Sb5+) |
|||
|
|
||||
|
# 1 |
9 3 3 |
5 μg Leish-111f in 25 μg MPL-SE + Sb5+ 25 μg MPL-SE + Sb5+ Placebo (saline) + Sb5+ |
Day 0, Day 28 and Day 56 |
SMC1 |
|
# 2* |
9 3 3 |
10 μg Leish-111f in 25 μg MPL-SE + Sb5+ 25 μg MPL-SE + Sb5+ Placebo (saline) + Sb5+ |
Day 0, Day 28 and Day 56 |
SMC1 |
|
# 3** |
9 32 3 |
20 μg Leish-111f in 25 μg MPL-SE + Sb5+ 25 μg MPL-SE + Sb5+ Placebo (saline) + Sb5+ |
Day 0, Day 28 and Day 56 |
SMC1 |
|
|
||||
|
1SMC = Standard multiple cycles: 10 days of pentavalent antimony (10 mg/kg IM or IV once daily) starting on Day 0, followed by 11 days of no antimony. Cycles are repeated until cure is achieved. 2Only 2 patients were randomized to adjuvant in the third cohort (inability to recruit 15 patients). Sequential enrollment of cohorts: * = after Day 84 of cohort 1; ** = after Day 84 of cohort 2. |
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|
Ghalib and Modabber Kinetoplastid Biology and Disease 2007 6:7 doi:10.1186/1475-9292-6-7 |
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