Trial Outcomes & Findings for Moxidectin for LF, Cote d'Ivoire (DOLF) (NCT NCT04410406)
NCT ID: NCT04410406
Last Updated: 2026-01-29
Results Overview
The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
12 months
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
IA (Ivermectin + Albendazole)
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
41
|
42
|
|
Overall Study
COMPLETED
|
25
|
16
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IA (Ivermectin + Albendazole)
n=29 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=22 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=32 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=30 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
22 Participants
n=22 Participants
|
32 Participants
n=32 Participants
|
30 Participants
n=30 Participants
|
113 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=113 Participants
|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 10.6 • n=29 Participants
|
37.3 years
STANDARD_DEVIATION 10.2 • n=22 Participants
|
38.3 years
STANDARD_DEVIATION 11.9 • n=32 Participants
|
39.7 years
STANDARD_DEVIATION 11.8 • n=30 Participants
|
37 years
STANDARD_DEVIATION 11.2 • n=113 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=29 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=30 Participants
|
10 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=29 Participants
|
20 Participants
n=22 Participants
|
30 Participants
n=32 Participants
|
26 Participants
n=30 Participants
|
103 Participants
n=113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Côte D'Ivoire
|
29 participants
n=29 Participants
|
22 participants
n=22 Participants
|
32 participants
n=32 Participants
|
30 participants
n=30 Participants
|
113 participants
n=113 Participants
|
|
Blood microfilaria count, median (IQR)
|
342 Mf/mL
n=29 Participants
|
134 Mf/mL
n=22 Participants
|
204.5 Mf/mL
n=32 Participants
|
191.5 Mf/mL
n=30 Participants
|
209 Mf/mL
n=113 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=25 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=19 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Clearance of Microfilaremia (IA vs. MoxA)
|
8 Participants
|
18 Participants
|
24 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment.
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=25 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=16 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=22 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=23 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Clearance of Microfilaremia (IDA vs. MoxDA)
|
13 Participants
|
14 Participants
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 24, & 36 monthsPopulation: The number of participants analyzed at different time points differs because we were unable to follow everyone consistently in the field at all timepoints. In many cases, our participants may need to leave for farming or other seasonal obligations.
The proportion of participants in each study arm with complete clearance of W. bancrofti microfilaremia at 6, 12, 24, \& 36 months after treatment.
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=28 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=23 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=31 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=34 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Clearance of Microfilaremia
24 months
|
13 Participants
|
14 Participants
|
20 Participants
|
21 Participants
|
|
Clearance of Microfilaremia
36 months
|
22 Participants
|
20 Participants
|
30 Participants
|
32 Participants
|
|
Clearance of Microfilaremia
6 months
|
8 Participants
|
15 Participants
|
20 Participants
|
24 Participants
|
|
Clearance of Microfilaremia
12 months
|
8 Participants
|
18 Participants
|
24 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 monthsPopulation: Mean microfilaria counts
Change in microfilariae counts (relative to baseline) at12 \& 24 months
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=25 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=19 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Change in Mf Counts
12 Months
|
20.70 Mf/mL
Interval 12.1 to 35.4
|
0.48 Mf/mL
Interval 0.07 to 3.1
|
1.30 Mf/mL
Interval 0.46 to 3.4
|
0.05 Mf/mL
Interval 0.01 to 0.42
|
|
Change in Mf Counts
24 Months
|
8.10 Mf/mL
Interval 3.1 to 21.4
|
2.50 Mf/mL
Interval 0.57 to 10.6
|
2.00 Mf/mL
Interval 0.32 to 12.7
|
0.70 Mf/mL
Interval 0.12 to 4.2
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reportedPopulation: Geometric mean of circulating filarial antigen ng/mL at 12 and 24 months
Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 12 \& 24 months
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=25 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=19 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Reduction in Circulating Filarial Antigen (CFA) Counts
12 Months
|
21.70 ng/mL
Interval 13.6 to 34.6
|
12.50 ng/mL
Interval 7.3 to 21.4
|
10.30 ng/mL
Interval 6.6 to 16.2
|
7.80 ng/mL
Interval 4.8 to 12.6
|
|
Reduction in Circulating Filarial Antigen (CFA) Counts
24 Months
|
12.16 ng/mL
Interval 7.53 to 19.65
|
6.38 ng/mL
Interval 3.7 to 11.01
|
5.14 ng/mL
Interval 3.16 to 8.69
|
4.76 ng/mL
Interval 2.89 to 7.84
|
SECONDARY outcome
Timeframe: 6, 12, & 24 monthsPopulation: Participants with worm nest clearance (MALES ONLY)
Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment in male participants only
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=25 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=19 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=28 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=26 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Inactivation of Adult Worm Nests in Male Participants Only
12 Months
|
1 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
|
Inactivation of Adult Worm Nests in Male Participants Only
24 Months
|
4 Participants
|
8 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From baseline treatment to 7 days post-treatmentPopulation: Frequency of AEs
Frequency and severity of AEs during the first 7 days after treatment.
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=41 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=40 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=41 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=42 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Frequency and Severity of AEs
|
22 Participants
|
24 Participants
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatmentPopulation: Dose Normalized AUC (ng\*hr/mL)
Noncompartmental pharmacokinetic analyses of DEC, ABZ, ABZSO, ABZSO2, IVM and Mox concentrations will be conducted using WinNonlin (Pharsight Corporation; Cary, North Carolina, USA). Drug plasma concentrations and computed pharmacokinetic parameters will be listed by subject and summarized by drug or metabolite (geometric mean with coefficient of variation, arithmetic mean with standard deviation, minimum, maximum, number of observations). Individual and geometric mean (by time) concentrations versus time will be plotted for each treatment group on both linear and natural logarithm scales.
Outcome measures
| Measure |
IA (Ivermectin + Albendazole)
n=15 Participants
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=15 Participants
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=14 Participants
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=14 Participants
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
Plasma Levels of Drugs/Metabolites Post Treatment
ALB
|
116.2 ng*hr/mL
Interval 10.0 to 686.3
|
172.1 ng*hr/mL
Interval 8.0 to 648.7
|
124.2 ng*hr/mL
Interval 9.9 to 366.2
|
82.4 ng*hr/mL
Interval 12.9 to 386.6
|
|
Plasma Levels of Drugs/Metabolites Post Treatment
ALB-OX
|
3302.3 ng*hr/mL
Interval 1355.5 to 11146.8
|
4078.9 ng*hr/mL
Interval 897.4 to 5738.5
|
3512.5 ng*hr/mL
Interval 1264.8 to 9680.3
|
2595.8 ng*hr/mL
Interval 897.4 to 5738.5
|
|
Plasma Levels of Drugs/Metabolites Post Treatment
ALB-ON
|
187.3 ng*hr/mL
Interval 43.2 to 593.9
|
300.8 ng*hr/mL
Interval 89.2 to 775.0
|
217.1 ng*hr/mL
Interval 79.5 to 613.5
|
174 ng*hr/mL
Interval 89.4 to 466.2
|
|
Plasma Levels of Drugs/Metabolites Post Treatment
DEC
|
—
|
—
|
21308.2 ng*hr/mL
Interval 11177.4 to 28869.3
|
19544.9 ng*hr/mL
Interval 12412.9 to 28740.7
|
|
Plasma Levels of Drugs/Metabolites Post Treatment
IVM
|
1505.1 ng*hr/mL
Interval 606.5 to 3318.4
|
—
|
1690.9 ng*hr/mL
Interval 885.5 to 3222.2
|
—
|
|
Plasma Levels of Drugs/Metabolites Post Treatment
MOX
|
—
|
2530.8 ng*hr/mL
Interval 549.2 to 5933.8
|
—
|
2653.2 ng*hr/mL
Interval 993.5 to 7507.8
|
Adverse Events
IA (Ivermectin + Albendazole)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
MoxA (Moxidectin + Albendazole)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 2 deaths
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 2 deaths
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IA (Ivermectin + Albendazole)
n=41 participants at risk
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=40 participants at risk
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=41 participants at risk
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=42 participants at risk
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.5%
1/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
4.9%
2/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Seizure
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.5%
1/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
Other adverse events
| Measure |
IA (Ivermectin + Albendazole)
n=41 participants at risk
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxA (Moxidectin + Albendazole)
n=40 participants at risk
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
n=41 participants at risk
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Ivermectin: Ivermectin (IVM) 200 µg/kg
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
|
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
n=42 participants at risk
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Diethylcarbamazine: Diethylcarbamazine (DEC) 6mg/kg
Albendazole: Albendazole (ABZ) 400 mg
Moxidectin: Moxidectin (Mox) 8 mg
|
|---|---|---|---|---|
|
General disorders
Cough
|
4.9%
2/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
4.8%
2/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Diarrhea
|
12.2%
5/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.5%
3/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.3%
3/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
9.5%
4/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Difficulty Breathing
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Dizziness, giddiness, or fainting
|
12.2%
5/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.5%
1/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
9.5%
4/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Fatigue
|
2.4%
1/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
5.0%
2/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Headache
|
22.0%
9/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
10.0%
4/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.3%
3/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
11.9%
5/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Itching Skin
|
4.9%
2/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
17.5%
7/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
4.8%
2/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Muscle or Joint Pain
|
12.2%
5/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
27.5%
11/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
12.2%
5/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
11.9%
5/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Nausea
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.3%
3/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Swollen or Painful Nodules
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Testicular or Scrotal Pain
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.3%
3/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.1%
3/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Vomiting
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
General disorders
Other
|
0.00%
0/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
0.00%
0/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
7.3%
3/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
2.4%
1/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.1%
7/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
5.0%
2/40 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
9.8%
4/41 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
4.8%
2/42 • Active adverse event monitoring took place from treatment to 7 days post-treatment. Passive adverse event monitoring continued through 36-months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place