Trial Outcomes & Findings for Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria (NCT NCT00440999)

Last Updated: 2021-11-02

Results Overview

Cure rate on Day 14 is defined as the absence of P. vivax parasitaemia on Day 14 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

456 participants

Primary outcome timeframe

Day 14

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pyronaridine - Artesunate Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Overall Study STARTED	228	228
Overall Study COMPLETED	193	187
Overall Study NOT COMPLETED	35	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Pyronaridine - Artesunate Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	6	7
Overall Study Lost to Follow-up	19	12
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	5
Overall Study Subjets missed the visit	1	0
Overall Study Mixed infection at entry	1	0
Overall Study P. falciparum malaria	5	14
Overall Study Subj left hosp without inform staff	0	1

Baseline Characteristics

Subjects total and per country/site

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 14

Population: Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=218 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=209 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Crude Cure Rate on Day 14 Total cured	217 Participants	209 Participants
Crude Cure Rate on Day 14 Cambodia	75 Participants	73 Participants
Crude Cure Rate on Day 14 India	33 Participants	33 Participants
Crude Cure Rate on Day 14 Indonesia/Maumere	11 Participants	10 Participants
Crude Cure Rate on Day 14 Thailand/Mae Sot	49 Participants	46 Participants
Crude Cure Rate on Day 14 Thailand/Mae Ramat	50 Participants	47 Participants
Crude Cure Rate on Day 14 baseline P. vivax = 250-5,000/uL	69 Participants	80 Participants
Crude Cure Rate on Day 14 baseline P. vivax = >5,000/uL-10,000/uL	58 Participants	59 Participants
Crude Cure Rate on Day 14 baseline P. vivax = >10,000/uL	89 Participants	70 Participants
Crude Cure Rate on Day 14 age ≤ 12 years	13 Participants	11 Participants
Crude Cure Rate on Day 14 age ≥ 12 years	204 Participants	198 Participants
Crude Cure Rate on Day 14 Gender - Male	164 Participants	148 Participants
Crude Cure Rate on Day 14 Gender - Female	53 Participants	61 Participants
Crude Cure Rate on Day 14 Previous P. vivax episode in the past = no	107 Participants	93 Participants
Crude Cure Rate on Day 14 Previous P. vivax episode in the past = yes	110 Participants	116 Participants

SECONDARY outcome

Timeframe: Day 21 and 28

Cure on Day 21 and 28 is defined as the absence of P. vivax parasitaemia on Day 21 and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=218 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=209 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Crude Cure Rate on Days 21 and 28. Cure rate (%) at Day 21	99.5 percentage of cured subjects Interval 97.4 to 100.0	99.5 percentage of cured subjects Interval 97.3 to 100.0
Crude Cure Rate on Days 21 and 28. Cure rate (%) at Day 28	97.1 percentage of cured subjects Interval 93.8 to 98.9	98.0 percentage of cured subjects Interval 94.9 to 99.4

SECONDARY outcome

Timeframe: Days 0 to 42

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=218 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=209 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Parasite Clearance Time	23.1 hours Interval 16.3 to 23.5	32.0 hours Interval 31.7 to 32.0

SECONDARY outcome

Timeframe: Days 0 to 42

Fever clearance time is defined as the time from first dosing to the first normal reading of temperature (\<37.5°C for axillary/tympanic or \<38°C for oral/rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=168 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=154 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Fever Clearance Time	15.8 hours Interval 15.5 to 16.0	23.8 hours Interval 16.0 to 24.0

SECONDARY outcome

Timeframe: Days 1, 2, and 3

Percentage of subjects with parasite clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose).

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=218 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=209 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 1 (24h after first dose)	71.6 percentage of subjects Interval 65.6 to 77.5	30.6 percentage of subjects Interval 24.4 to 36.9
Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 2 (48h after first dose)	99.5 percentage of subjects Interval 98.6 to 100.0	88.0 percentage of subjects Interval 83.6 to 92.4
Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 3 (72h after first dose)	100.0 percentage of subjects Interval 100.0 to 100.0	96.7 percentage of subjects Interval 94.2 to 99.1

SECONDARY outcome

Timeframe: Day 1, 2, and 3

Percentage of subjects with fever clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose).

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=168 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=154 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Percentage of Subjects With Fever Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 1 (24h after first dose)	78.6 percentage of subjects Interval 72.4 to 84.8	58.4 percentage of subjects Interval 50.7 to 66.2
Percentage of Subjects With Fever Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 2 (48h after first dose)	89.9 percentage of subjects Interval 85.3 to 94.4	88.3 percentage of subjects Interval 83.2 to 93.4
Percentage of Subjects With Fever Clearance on Days 1, 2, and 3 Clearance rate (%) at Day 3 (72h after first dose)	97.0 percentage of subjects Interval 94.5 to 99.6	97.4 percentage of subjects Interval 94.9 to 99.9

SECONDARY outcome

Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

Population: Safety population consists of all randomized subjects who received any amount of study medication, subjects were analyzed as treated.

Number of participants with adverse events, including clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=228 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=228 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Number of Participants With Adverse Events Nr subj. with ≥1 AE	92 Participants	72 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 treatment-related AE	27 Participants	23 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 SAE	2 Participants	0 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 treatment-related SAE	0 Participants	0 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 severe or life-threatening AE	0 Participants	2 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 AE leading to death	0 Participants	0 Participants
Number of Participants With Adverse Events Nr subj. ≥1 AE leading to study drug discontinuation	0 Participants	2 Participants
Number of Participants With Adverse Events Nr subj. with ≥1 AE leading to study withdrawal	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14, 21, and 28

Cure on Days 14, 21, and 28 is defined as the absence of P. vivax parasitaemia on Days 14, 21, and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=216 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=200 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28 Cure rate (%) at Day 14	100.0 percentage of subjects Interval 98.3 to 100.0	99.5 percentage of subjects Interval 97.2 to 100.0
Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28 Cure rate (%) at Day 21	100.0 percentage of subjects Interval 98.3 to 100.0	99.5 percentage of subjects Interval 97.2 to 100.0
Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28 Cure rate (%) at Day 28	98.1 percentage of subjects Interval 95.1 to 99.4	97.9 percentage of subjects Interval 94.8 to 99.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 42

Cure on Day 42 is defined as the absence of P. vivax parasitaemia on Day 42 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period.

Outcome measures

Outcome measures
Measure	Pyronaridine Artesunate n=216 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (Day 0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=200 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (Day 0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Percentage of Subjects With Crude and PCR-corrected Cure Rate on Day 42 Crude cure rate (%)	95.5 percentage of subjects Interval 91.6 to 97.9	92.1 percentage of subjects Interval 87.3 to 95.5
Percentage of Subjects With Crude and PCR-corrected Cure Rate on Day 42 PCR-corrected cure rate (%)	95.0 percentage of subjects Interval 91.0 to 97.6	94.1 percentage of subjects Interval 89.8 to 97.0

Adverse Events

Pyronaridine Artesunate

Serious events: 2 serious events

Other events: 90 other events

Deaths: 2 deaths

Chloroquine

Serious events: 0 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pyronaridine Artesunate n=228 participants at risk Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=228 participants at risk Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
General disorders Pyrexia	0.44% 1/228 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	0.00% 0/228 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Infections and infestations Typhoid fever	0.44% 1/228 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	0.00% 0/228 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

Other adverse events

Other adverse events
Measure	Pyronaridine Artesunate n=228 participants at risk Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=228 participants at risk Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
General disorders Fatigue	5.3% 12/228 • Number of events 12 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	4.8% 11/228 • Number of events 11 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Infections and infestations Nasopharyngitis	5.7% 13/228 • Number of events 15 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	2.6% 6/228 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Metabolism and nutrition disorders Anorexia	8.3% 19/228 • Number of events 19 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	4.4% 10/228 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Musculoskeletal and connective tissue disorders Myalgia	13.2% 30/228 • Number of events 30 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	9.2% 21/228 • Number of events 22 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Nervous system disorders Headache	19.7% 45/228 • Number of events 52 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier	14.9% 34/228 • Number of events 40 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

Additional Information

Stephan Duparc, MD

Medicines for Malaria Venture

Phone: +41 22 555 0300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pyronaridine - Artesunate n=228 Participants Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2). Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg.	Chloroquine n=228 Participants Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2). The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.	Total n=456 Participants Total of all reporting groups
Age, Continuous Total	27.0 years STANDARD_DEVIATION 11.7 • n=228 Participants • Subjects total and per country/site	26.4 years STANDARD_DEVIATION 10.93 • n=228 Participants • Subjects total and per country/site	26.7 years STANDARD_DEVIATION 11.04 • n=456 Participants • Subjects total and per country/site
Age, Continuous Cambodia	21.0 years STANDARD_DEVIATION 8.93 • n=77 Participants • Subjects total and per country/site	23.0 years STANDARD_DEVIATION 9.92 • n=77 Participants • Subjects total and per country/site	22.0 years STANDARD_DEVIATION 9.46 • n=154 Participants • Subjects total and per country/site
Age, Continuous India	31.5 years STANDARD_DEVIATION 12.20 • n=39 Participants • Subjects total and per country/site	27.9 years STANDARD_DEVIATION 11.99 • n=41 Participants • Subjects total and per country/site	29.7 years STANDARD_DEVIATION 12.15 • n=80 Participants • Subjects total and per country/site
Age, Continuous Indonesia/Maumere	26.7 years STANDARD_DEVIATION 10.59 • n=13 Participants • Subjects total and per country/site	18.6 years STANDARD_DEVIATION 9.07 • n=11 Participants • Subjects total and per country/site	23.0 years STANDARD_DEVIATION 10.54 • n=24 Participants • Subjects total and per country/site
Age, Continuous Thailand/Mae Sot	29.6 years STANDARD_DEVIATION 11.15 • n=49 Participants • Subjects total and per country/site	29.6 years STANDARD_DEVIATION 9.80 • n=50 Participants • Subjects total and per country/site	29.6 years STANDARD_DEVIATION 10.44 • n=99 Participants • Subjects total and per country/site
Age, Continuous Thailand/Mae Ramat	30.5 years STANDARD_DEVIATION 9.93 • n=50 Participants • Subjects total and per country/site	29.0 years STANDARD_DEVIATION 11.04 • n=49 Participants • Subjects total and per country/site	29.7 years STANDARD_DEVIATION 10.47 • n=99 Participants • Subjects total and per country/site
Age, Customized ≤12 years	14 Participants n=228 Participants	13 Participants n=228 Participants	27 Participants n=456 Participants
Age, Customized >12 years	214 Participants n=228 Participants	215 Participants n=228 Participants	429 Participants n=456 Participants
Sex: Female, Male Total · Female	56 Participants n=228 Participants • Subjects total and per country/site	64 Participants n=228 Participants • Subjects total and per country/site	120 Participants n=456 Participants • Subjects total and per country/site
Sex: Female, Male Total · Male	172 Participants n=228 Participants • Subjects total and per country/site	164 Participants n=228 Participants • Subjects total and per country/site	336 Participants n=456 Participants • Subjects total and per country/site
Sex: Female, Male Cambodia · Female	25 Participants n=77 Participants • Subjects total and per country/site	27 Participants n=77 Participants • Subjects total and per country/site	52 Participants n=154 Participants • Subjects total and per country/site
Sex: Female, Male Cambodia · Male	52 Participants n=77 Participants • Subjects total and per country/site	50 Participants n=77 Participants • Subjects total and per country/site	102 Participants n=154 Participants • Subjects total and per country/site
Sex: Female, Male India · Female	5 Participants n=39 Participants • Subjects total and per country/site	7 Participants n=41 Participants • Subjects total and per country/site	12 Participants n=80 Participants • Subjects total and per country/site
Sex: Female, Male India · Male	34 Participants n=39 Participants • Subjects total and per country/site	34 Participants n=41 Participants • Subjects total and per country/site	68 Participants n=80 Participants • Subjects total and per country/site
Sex: Female, Male Indonesia/Maumere · Female	6 Participants n=13 Participants • Subjects total and per country/site	3 Participants n=11 Participants • Subjects total and per country/site	9 Participants n=24 Participants • Subjects total and per country/site
Sex: Female, Male Indonesia/Maumere · Male	7 Participants n=13 Participants • Subjects total and per country/site	8 Participants n=11 Participants • Subjects total and per country/site	15 Participants n=24 Participants • Subjects total and per country/site
Sex: Female, Male Thailand/Mae Sot · Female	11 Participants n=49 Participants • Subjects total and per country/site	11 Participants n=50 Participants • Subjects total and per country/site	22 Participants n=99 Participants • Subjects total and per country/site
Sex: Female, Male Thailand/Mae Sot · Male	38 Participants n=49 Participants • Subjects total and per country/site	39 Participants n=50 Participants • Subjects total and per country/site	77 Participants n=99 Participants • Subjects total and per country/site
Sex: Female, Male Thailand/Mae Ramat · Female	9 Participants n=50 Participants • Subjects total and per country/site	16 Participants n=49 Participants • Subjects total and per country/site	25 Participants n=99 Participants • Subjects total and per country/site
Sex: Female, Male Thailand/Mae Ramat · Male	41 Participants n=50 Participants • Subjects total and per country/site	33 Participants n=49 Participants • Subjects total and per country/site	74 Participants n=99 Participants • Subjects total and per country/site
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Race (NIH/OMB) Asian	228 Participants n=228 Participants	228 Participants n=228 Participants	456 Participants n=456 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Race (NIH/OMB) Black or African American	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Race (NIH/OMB) White	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Race (NIH/OMB) More than one race	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=228 Participants	0 Participants n=228 Participants	0 Participants n=456 Participants
Region of Enrollment Cambodia	77 participants n=228 Participants	77 participants n=228 Participants	154 participants n=456 Participants
Region of Enrollment Thailand	99 participants n=228 Participants	99 participants n=228 Participants	198 participants n=456 Participants
Region of Enrollment India	39 participants n=228 Participants	41 participants n=228 Participants	80 participants n=456 Participants
Region of Enrollment Indonesia	13 participants n=228 Participants	11 participants n=228 Participants	24 participants n=456 Participants