Trial Outcomes & Findings for Chemopreventive Therapy for Malaria in Ugandan Children (NCT NCT00948896)
NCT ID: NCT00948896
Last Updated: 2015-11-24
Results Overview
The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
6 to 24 months of age
Results posted on
2015-11-24
Participant Flow
Convenience sampling was used to enroll a cohort of 600 infants 4-5 months of age from the Tororo District Hospital Maternal and Child Health clinic between June 2010 and July 2011.
Of the 400 HIV-unexposed infants, 7 were excluded prior to randomization for inability to comply with study protocol. Of the 200 HIV-exposed infants, 14 were excluded prior to randomization for the following reasons: 7 tested HIV positive; 3 unable to locate for \> 60 days; 2 withdrew informed consent; 1 died; 1 unable to comply with protocol.
Participant milestones
| Measure |
HIV-unexposed & No Chemoprevention
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & SP
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & TS
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & DP
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
HIV-exposed No chemoprevention was given
|
HIV-exposed & SP
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & TS
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & DP
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Randomization to 24 Months of Age
STARTED
|
98
|
98
|
99
|
98
|
46
|
46
|
47
|
47
|
|
Randomization to 24 Months of Age
COMPLETED
|
90
|
85
|
90
|
87
|
44
|
42
|
43
|
45
|
|
Randomization to 24 Months of Age
NOT COMPLETED
|
8
|
13
|
9
|
11
|
2
|
4
|
4
|
2
|
|
24 Months of Age to 36 Months of Age
STARTED
|
90
|
85
|
90
|
87
|
44
|
42
|
43
|
45
|
|
24 Months of Age to 36 Months of Age
COMPLETED
|
87
|
83
|
85
|
85
|
43
|
40
|
43
|
45
|
|
24 Months of Age to 36 Months of Age
NOT COMPLETED
|
3
|
2
|
5
|
2
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
HIV-unexposed & No Chemoprevention
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & SP
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & TS
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & DP
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
HIV-exposed No chemoprevention was given
|
HIV-exposed & SP
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & TS
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & DP
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Randomization to 24 Months of Age
Death
|
1
|
0
|
0
|
0
|
2
|
1
|
2
|
1
|
|
Randomization to 24 Months of Age
Withdrawal by Subject
|
3
|
5
|
4
|
4
|
0
|
1
|
0
|
0
|
|
Randomization to 24 Months of Age
Lost to Follow-up
|
4
|
4
|
2
|
5
|
0
|
0
|
1
|
0
|
|
Randomization to 24 Months of Age
Protocol Violation
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Randomization to 24 Months of Age
Moved out of Study Area
|
0
|
3
|
3
|
1
|
0
|
2
|
0
|
0
|
|
24 Months of Age to 36 Months of Age
Death
|
0
|
2
|
2
|
0
|
0
|
1
|
0
|
0
|
|
24 Months of Age to 36 Months of Age
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
24 Months of Age to 36 Months of Age
Lost to Follow-up
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
24 Months of Age to 36 Months of Age
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
24 Months of Age to 36 Months of Age
Moved out of Study Area
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Chemopreventive Therapy for Malaria in Ugandan Children
Baseline characteristics by cohort
| Measure |
HIV-unexposed & no Chemoprevention
n=98 Participants
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=98 Participants
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=99 Participants
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=98 Participants
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
n=46 Participants
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
n=46 Participants
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
n=47 Participants
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
n=47 Participants
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
Total
n=579 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Stunted
No
|
88 participants
n=5 Participants
|
87 participants
n=7 Participants
|
93 participants
n=5 Participants
|
94 participants
n=4 Participants
|
40 participants
n=21 Participants
|
39 participants
n=10 Participants
|
41 participants
n=115 Participants
|
40 participants
n=6 Participants
|
522 participants
n=6 Participants
|
|
Wasted
Yes
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=10 Participants
|
1 participants
n=115 Participants
|
4 participants
n=6 Participants
|
32 participants
n=6 Participants
|
|
Age, Continuous
|
5.4 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
5.3 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
5.4 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
5.4 months
STANDARD_DEVIATION 0.5 • n=4 Participants
|
4.8 months
STANDARD_DEVIATION 0.7 • n=21 Participants
|
4.7 months
STANDARD_DEVIATION 0.7 • n=10 Participants
|
4.8 months
STANDARD_DEVIATION 0.8 • n=115 Participants
|
4.7 months
STANDARD_DEVIATION 0.8 • n=6 Participants
|
5.2 months
STANDARD_DEVIATION 0.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
287 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
22 Participants
n=6 Participants
|
292 Participants
n=6 Participants
|
|
Slept under any bednet prior night
Yes
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
40 participants
n=5 Participants
|
45 participants
n=4 Participants
|
27 participants
n=21 Participants
|
27 participants
n=10 Participants
|
26 participants
n=115 Participants
|
29 participants
n=6 Participants
|
278 participants
n=6 Participants
|
|
Slept under any bednet prior night
No
|
57 participants
n=5 Participants
|
55 participants
n=7 Participants
|
59 participants
n=5 Participants
|
53 participants
n=4 Participants
|
19 participants
n=21 Participants
|
19 participants
n=10 Participants
|
21 participants
n=115 Participants
|
18 participants
n=6 Participants
|
301 participants
n=6 Participants
|
|
Slept under ITN prior night
Yes
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
27 participants
n=5 Participants
|
29 participants
n=4 Participants
|
22 participants
n=21 Participants
|
24 participants
n=10 Participants
|
19 participants
n=115 Participants
|
22 participants
n=6 Participants
|
200 participants
n=6 Participants
|
|
Slept under ITN prior night
No
|
71 participants
n=5 Participants
|
68 participants
n=7 Participants
|
72 participants
n=5 Participants
|
69 participants
n=4 Participants
|
24 participants
n=21 Participants
|
22 participants
n=10 Participants
|
28 participants
n=115 Participants
|
25 participants
n=6 Participants
|
379 participants
n=6 Participants
|
|
Stunted
Yes
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
6 participants
n=115 Participants
|
7 participants
n=6 Participants
|
57 participants
n=6 Participants
|
|
Wasted
No
|
94 participants
n=5 Participants
|
91 participants
n=7 Participants
|
92 participants
n=5 Participants
|
93 participants
n=4 Participants
|
46 participants
n=21 Participants
|
42 participants
n=10 Participants
|
46 participants
n=115 Participants
|
43 participants
n=6 Participants
|
547 participants
n=6 Participants
|
|
Hemoglobin
|
9.7 gm/dl
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9.6 gm/dl
STANDARD_DEVIATION 1.8 • n=7 Participants
|
9.9 gm/dl
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.5 gm/dl
STANDARD_DEVIATION 1.5 • n=4 Participants
|
10.1 gm/dl
STANDARD_DEVIATION 1.2 • n=21 Participants
|
10.0 gm/dl
STANDARD_DEVIATION 1.4 • n=10 Participants
|
10.1 gm/dl
STANDARD_DEVIATION 1.1 • n=115 Participants
|
10.5 gm/dl
STANDARD_DEVIATION 1.5 • n=6 Participants
|
9.8 gm/dl
STANDARD_DEVIATION 1.5 • n=6 Participants
|
|
Positive thick blood smear
Yes
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
17 participants
n=5 Participants
|
28 participants
n=4 Participants
|
8 participants
n=21 Participants
|
4 participants
n=10 Participants
|
8 participants
n=115 Participants
|
6 participants
n=6 Participants
|
120 participants
n=6 Participants
|
|
Positive thick blood smear
No
|
76 participants
n=5 Participants
|
71 participants
n=7 Participants
|
82 participants
n=5 Participants
|
70 participants
n=4 Participants
|
38 participants
n=21 Participants
|
42 participants
n=10 Participants
|
39 participants
n=115 Participants
|
41 participants
n=6 Participants
|
459 participants
n=6 Participants
|
|
Taking TS prophylaxis
Yes
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
5 participants
n=21 Participants
|
7 participants
n=10 Participants
|
5 participants
n=115 Participants
|
9 participants
n=6 Participants
|
NA participants
n=6 Participants
|
|
Taking TS prophylaxis
No
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
NA participants
n=4 Participants
|
41 participants
n=21 Participants
|
39 participants
n=10 Participants
|
42 participants
n=115 Participants
|
38 participants
n=6 Participants
|
NA participants
n=6 Participants
|
|
Age at time of randomization
|
6.0 months
n=5 Participants
|
6.0 months
n=7 Participants
|
6.0 months
n=5 Participants
|
6.0 months
n=4 Participants
|
10.0 months
n=21 Participants
|
9.3 months
n=10 Participants
|
11.6 months
n=115 Participants
|
10.3 months
n=6 Participants
|
6.0 months
n=6 Participants
|
|
Duration of follow-up
|
547 days
n=5 Participants
|
547 days
n=7 Participants
|
547 days
n=5 Participants
|
547 days
n=4 Participants
|
427 days
n=21 Participants
|
420 days
n=10 Participants
|
346 days
n=115 Participants
|
409 days
n=6 Participants
|
546 days
n=6 Participants
|
PRIMARY outcome
Timeframe: 6 to 24 months of ageThe incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.
Outcome measures
| Measure |
HIV-unexposed & no Chemoprevention
n=98 Participants
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=98 Participants
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=99 Participants
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=98 Participants
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
6-24 mo. of Age
|
6.95 Episode per person year at risk
|
6.73 Episode per person year at risk
|
5.21 Episode per person year at risk
|
3.02 Episode per person year at risk
|
—
|
—
|
—
|
—
|
|
Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
6-11 mo. of Age
|
6.41 Episode per person year at risk
|
5.51 Episode per person year at risk
|
3.27 Episode per person year at risk
|
1.49 Episode per person year at risk
|
—
|
—
|
—
|
—
|
|
Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
12-24 mo. of Age
|
7.24 Episode per person year at risk
|
7.41 Episode per person year at risk
|
6.32 Episode per person year at risk
|
3.88 Episode per person year at risk
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Randomization to 24 months of ageThe primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.
Outcome measures
| Measure |
HIV-unexposed & no Chemoprevention
n=46 Participants
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=46 Participants
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=47 Participants
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=47 Participants
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
Randomization - 24 mo. of Age
|
6.28 Episodes per person year at risk
|
4.50 Episodes per person year at risk
|
2.86 Episodes per person year at risk
|
1.83 Episodes per person year at risk
|
—
|
—
|
—
|
—
|
|
Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
Randomization -16 mo. of Age
|
5.42 Episodes per person year at risk
|
3.72 Episodes per person year at risk
|
1.70 Episodes per person year at risk
|
0.90 Episodes per person year at risk
|
—
|
—
|
—
|
—
|
|
Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
17-24 mo. of Age
|
7.04 Episodes per person year at risk
|
5.22 Episodes per person year at risk
|
3.79 Episodes per person year at risk
|
2.67 Episodes per person year at risk
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization until 24 months of ageNIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004
Outcome measures
| Measure |
HIV-unexposed & no Chemoprevention
n=98 Participants
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=98 Participants
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=99 Participants
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=98 Participants
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
n=46 Participants
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
n=46 Participants
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
n=47 Participants
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
n=47 Participants
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Grade 3-4 AEs possibly related to study drugs
|
NA incidence per person-year at risk
No study drugs taken.
|
0.056 incidence per person-year at risk
|
0.054 incidence per person-year at risk
|
0.021 incidence per person-year at risk
|
NA incidence per person-year at risk
No study drugs taken.
|
0 incidence per person-year at risk
|
0.062 incidence per person-year at risk
|
0.097 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
All serious adverse events
|
0.178 incidence per person-year at risk
|
0.364 incidence per person-year at risk
|
0.196 incidence per person-year at risk
|
0.091 incidence per person-year at risk
|
0.411 incidence per person-year at risk
|
0.453 incidence per person-year at risk
|
0.330 incidence per person-year at risk
|
0.194 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Anemia
|
0.384 incidence per person-year at risk
|
0.602 incidence per person-year at risk
|
0.318 incidence per person-year at risk
|
0.168 incidence per person-year at risk
|
0.705 incidence per person-year at risk
|
0.631 incidence per person-year at risk
|
0.206 incidence per person-year at risk
|
0.291 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Thrombocytopenia
|
0.123 incidence per person-year at risk
|
0.119 incidence per person-year at risk
|
0.061 incidence per person-year at risk
|
0.035 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0.118 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0.058 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Elevated aspartate aminotransferase
|
0.048 incidence per person-year at risk
|
0.056 incidence per person-year at risk
|
0.041 incidence per person-year at risk
|
0.021 incidence per person-year at risk
|
0.039 incidence per person-year at risk
|
0.020 incidence per person-year at risk
|
0.041 incidence per person-year at risk
|
0.039 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Elevated alanine aminotransferase
|
0.027 incidence per person-year at risk
|
0.028 incidence per person-year at risk
|
0.027 incidence per person-year at risk
|
0.021 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Neutropenia
|
0.021 incidence per person-year at risk
|
0.042 incidence per person-year at risk
|
0.014 incidence per person-year at risk
|
0.007 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
All grade 3-4 adverse events
|
1.159 incidence per person-year at risk
|
1.415 incidence per person-year at risk
|
0.914 incidence per person-year at risk
|
0.611 incidence per person-year at risk
|
1.214 incidence per person-year at risk
|
1.478 incidence per person-year at risk
|
0.659 incidence per person-year at risk
|
0.678 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Elevated Temperature
|
0.542 incidence per person-year at risk
|
0.546 incidence per person-year at risk
|
0.393 incidence per person-year at risk
|
0.323 incidence per person-year at risk
|
0.431 incidence per person-year at risk
|
0.532 incidence per person-year at risk
|
0.206 incidence per person-year at risk
|
0.174 incidence per person-year at risk
|
|
Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
Malnutrition
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0 incidence per person-year at risk
|
0.020 incidence per person-year at risk
|
0.020 incidence per person-year at risk
|
0.021 incidence per person-year at risk
|
0.039 incidence per person-year at risk
|
SECONDARY outcome
Timeframe: 24 months to 36 months of ageOutcome measures
| Measure |
HIV-unexposed & no Chemoprevention
n=87 Participants
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=83 Participants
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=85 Participants
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=85 Participants
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
n=43 Participants
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
n=40 Participants
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
n=43 Participants
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
n=45 Participants
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
Complicated malaria
|
0.046 Incidence per person year at risk
|
0.132 Incidence per person year at risk
|
0.046 Incidence per person year at risk
|
0 Incidence per person year at risk
|
0.161 Incidence per person year at risk
|
0.147 Incidence per person year at risk
|
0.116 Incidence per person year at risk
|
0.044 Incidence per person year at risk
|
|
Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
All-cause hospital admissions
|
0.046 Incidence per person year at risk
|
0.452 Incidence per person year at risk
|
0.091 Incidence per person year at risk
|
0.023 Incidence per person year at risk
|
0.459 Incidence per person year at risk
|
0.318 Incidence per person year at risk
|
0.186 Incidence per person year at risk
|
0.089 Incidence per person year at risk
|
|
Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
All incident episodes of malaria
|
10.85 Incidence per person year at risk
|
11.98 Incidence per person year at risk
|
10.90 Incidence per person year at risk
|
10.77 Incidence per person year at risk
|
9.08 Incidence per person year at risk
|
6.75 Incidence per person year at risk
|
8.13 Incidence per person year at risk
|
6.78 Incidence per person year at risk
|
Adverse Events
HIV-unexposed & no Chemoprevention
Serious events: 22 serious events
Other events: 70 other events
Deaths: 0 deaths
HIV-unexposed & Monthly SP
Serious events: 25 serious events
Other events: 66 other events
Deaths: 0 deaths
HIV-unexposed & Daily TS
Serious events: 20 serious events
Other events: 58 other events
Deaths: 0 deaths
HIV-unexposed & Monthly DP
Serious events: 10 serious events
Other events: 49 other events
Deaths: 0 deaths
HIV-exposed & no Chemoprevention
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
HIV-exposed & Monthly SP
Serious events: 14 serious events
Other events: 28 other events
Deaths: 0 deaths
HIV-exposed & Daily TS
Serious events: 10 serious events
Other events: 11 other events
Deaths: 0 deaths
HIV-exposed & Monthly DP
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-unexposed & no Chemoprevention
n=98 participants at risk
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=98 participants at risk
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=99 participants at risk
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=98 participants at risk
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
n=46 participants at risk
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
n=46 participants at risk
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
n=47 participants at risk
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
n=47 participants at risk
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.3%
2/46 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Anemia
|
15.3%
15/98 • Number of events 19 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
20.4%
20/98 • Number of events 45 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
14.1%
14/99 • Number of events 20 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.1%
4/98 • Number of events 5 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
17.4%
8/46 • Number of events 19 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
23.9%
11/46 • Number of events 17 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
8.5%
4/47 • Number of events 6 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
10.6%
5/47 • Number of events 6 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Dehydration
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/98 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Nervous system disorders
Electrolyte imbalance
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Hepatobiliary disorders
Elevated ALT (SGPT)
|
5.1%
5/98 • Number of events 5 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/98 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Hepatobiliary disorders
Elevated AST (SGOT)
|
6.1%
6/98 • Number of events 7 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.0%
4/99 • Number of events 4 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Endocrine disorders
Elevated temperature
|
2.0%
2/98 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/99 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.3%
2/47 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Metabolism and nutrition disorders
Poor feeding
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Infections and infestations
Septicemia
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
3.1%
3/98 • Number of events 5 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
Other adverse events
| Measure |
HIV-unexposed & no Chemoprevention
n=98 participants at risk
HIV-unexposed No chemoprevention was given
|
HIV-unexposed & Monthly SP
n=98 participants at risk
HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-unexposed & Daily TS
n=99 participants at risk
HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-unexposed & Monthly DP
n=98 participants at risk
HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
HIV-exposed & no Chemoprevention
n=46 participants at risk
HIV-exposed No chemoprevention was given
|
HIV-exposed & Monthly SP
n=46 participants at risk
HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
|
HIV-exposed & Daily TS
n=47 participants at risk
HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
|
HIV-exposed & Monthly DP
n=47 participants at risk
HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.6%
31/98 • Number of events 39 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
28.6%
28/98 • Number of events 44 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
21.2%
21/99 • Number of events 28 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
17.3%
17/98 • Number of events 19 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
30.4%
14/46 • Number of events 18 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
23.9%
11/46 • Number of events 15 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
6.4%
3/47 • Number of events 4 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
14.9%
7/47 • Number of events 10 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Endocrine disorders
Chills
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Nervous system disorders
Electrolyte imbalance
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Hepatobiliary disorders
Elevated ALT (SGPT)
|
4.1%
4/98 • Number of events 4 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
3.0%
3/99 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.3%
2/46 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Hepatobiliary disorders
Elevated AST (SGOT)
|
5.1%
5/98 • Number of events 6 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
7.1%
7/98 • Number of events 8 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/99 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
4.3%
2/46 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Endocrine disorders
Elevated temperature
|
54.1%
53/98 • Number of events 77 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
50.0%
49/98 • Number of events 75 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
41.4%
41/99 • Number of events 58 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
32.7%
32/98 • Number of events 46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
37.0%
17/46 • Number of events 22 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
41.3%
19/46 • Number of events 27 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
19.1%
9/47 • Number of events 10 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
12.8%
6/47 • Number of events 8 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Renal and urinary disorders
Hyperglycemia
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/99 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.2%
1/46 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
3/98 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
6.1%
6/98 • Number of events 6 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.0%
2/99 • Number of events 2 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
2.1%
1/47 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Nervous system disorders
Seizure
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/99 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Infections and infestations
Septicemia
|
0.00%
0/98 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/99 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
1.0%
1/98 • Number of events 1 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.3%
15/98 • Number of events 15 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
7.1%
7/98 • Number of events 12 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
5.1%
5/99 • Number of events 8 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
5.1%
5/98 • Number of events 5 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/46 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
10.9%
5/46 • Number of events 6 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
0.00%
0/47 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
6.4%
3/47 • Number of events 3 • The adverse event data was collected in the time period between randomization and when intervention was stopped (24 mo. of Age).
|
Additional Information
Dr. Grant Dorsey
University of California, San Francisco
Phone: 415-206-4680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place