Trial Outcomes & Findings for Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (NCT NCT02163447)

Last Updated: 2024-12-18

Results Overview

Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

300 participants

Primary outcome timeframe

Delivery

Results posted on

2024-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Mothers - 3 Dose SP Sulfadoxine-Pyrimethamine 500mg/25mg	Mothers - 3 Dose DP Dihydrioartemisinin-Piperaquine 40mg/320mg	Mothers - Monthly DP Dihydroartemisinin-Piperaquine 20mg/160mg
Overall Study STARTED	106	94	100
Overall Study Infants Born	101	93	100
Overall Study COMPLETED	100	88	97
Overall Study NOT COMPLETED	6	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Mothers - 3 Dose SP Sulfadoxine-Pyrimethamine 500mg/25mg	Mothers - 3 Dose DP Dihydrioartemisinin-Piperaquine 40mg/320mg	Mothers - Monthly DP Dihydroartemisinin-Piperaquine 20mg/160mg
Overall Study Withdrawal by Subject	2	0	1
Overall Study Lost to Follow-up	1	3	0
Overall Study Moved out of study area	2	3	2
Overall Study Became HIV infected at time of delivery	1	0	0

Baseline Characteristics

Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mothers - 3 Dose SP n=106 Participants Sulfadoxine-Pyrimethamine 500mg/25mg	Mothers - 3 Dose DP n=94 Participants Dihydrioartemisinin-Piperaquine 40mg/320mg	Mothers - Monthly DP n=100 Participants Dihydroartemisinin-Piperaquine 20mg/160mg	Total n=300 Participants Total of all reporting groups
Age, Continuous	21.3 years STANDARD_DEVIATION 3.6 • n=5 Participants	22.2 years STANDARD_DEVIATION 4.3 • n=7 Participants	22.6 years STANDARD_DEVIATION 4.0 • n=5 Participants	22.0 years STANDARD_DEVIATION 4.0 • n=4 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	94 Participants n=7 Participants	100 Participants n=5 Participants	300 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	106 Participants n=5 Participants	94 Participants n=7 Participants	100 Participants n=5 Participants	300 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Gestation (weeks) 12 to 16 wk	75 Participants n=5 Participants	65 Participants n=7 Participants	67 Participants n=5 Participants	207 Participants n=4 Participants
Gestation (weeks) > 16 to 20 wk	31 Participants n=5 Participants	29 Participants n=7 Participants	33 Participants n=5 Participants	93 Participants n=4 Participants
Gravidity 1	42 Participants n=5 Participants	33 Participants n=7 Participants	36 Participants n=5 Participants	111 Participants n=4 Participants
Gravidity 2	32 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	88 Participants n=4 Participants
Gravidity >= 3	32 Participants n=5 Participants	33 Participants n=7 Participants	36 Participants n=5 Participants	101 Participants n=4 Participants
Bed-net ownership None	13 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Bed-net ownership Untreated Net	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Bed-net ownership Long lasting insecticide- treated net	92 Participants n=5 Participants	80 Participants n=7 Participants	89 Participants n=5 Participants	261 Participants n=4 Participants
Household wealth index Lowest third	38 Participants n=5 Participants	29 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants
Household wealth index Middle third	32 Participants n=5 Participants	37 Participants n=7 Participants	31 Participants n=5 Participants	100 Participants n=4 Participants
Household wealth index Highest third	36 Participants n=5 Participants	28 Participants n=7 Participants	36 Participants n=5 Participants	100 Participants n=4 Participants
Weight (kg)	55.4 kg STANDARD_DEVIATION 6.8 • n=5 Participants	55.6 kg STANDARD_DEVIATION 7.0 • n=7 Participants	55.5 kg STANDARD_DEVIATION 7.5 • n=5 Participants	55.5 kg STANDARD_DEVIATION 7.1 • n=4 Participants
Height (cm)	162.8 cm STANDARD_DEVIATION 6.8 • n=5 Participants	162.5 cm STANDARD_DEVIATION 6.7 • n=7 Participants	162.3 cm STANDARD_DEVIATION 7.7 • n=5 Participants	162.5 cm STANDARD_DEVIATION 7.1 • n=4 Participants
White blood cells per mm^3	6036 cells per mm^3 STANDARD_DEVIATION 2070 • n=5 Participants	6279 cells per mm^3 STANDARD_DEVIATION 1713 • n=7 Participants	6040 cells per mm^3 STANDARD_DEVIATION 1572 • n=5 Participants	6113 cells per mm^3 STANDARD_DEVIATION 1802 • n=4 Participants
Neutrophil cells per mm^3	3330 cells per mm^3 STANDARD_DEVIATION 1477 • n=5 Participants	3558 cells per mm^3 STANDARD_DEVIATION 1304 • n=7 Participants	3351 cells per mm^3 STANDARD_DEVIATION 1175 • n=5 Participants	3409 cells per mm^3 STANDARD_DEVIATION 1327 • n=4 Participants
Platelet cells per mm^3	198906 cells per mm^3 STANDARD_DEVIATION 60665 • n=5 Participants	201809 cells per mm^3 STANDARD_DEVIATION 67358 • n=7 Participants	195840 cells per mm^3 STANDARD_DEVIATION 59593 • n=5 Participants	198793 cells per mm^3 STANDARD_DEVIATION 62332 • n=4 Participants
Hemoglobin level g/dL	11.8 g/DL STANDARD_DEVIATION 1.5 • n=5 Participants	11.9 g/DL STANDARD_DEVIATION 1.1 • n=7 Participants	12.0 g/DL STANDARD_DEVIATION 1.4 • n=5 Participants	11.9 g/DL STANDARD_DEVIATION 1.3 • n=4 Participants
Alanine aminotransferase level IU/L	15.4 IU/L STANDARD_DEVIATION 7.5 • n=5 Participants	14.9 IU/L STANDARD_DEVIATION 5.8 • n=7 Participants	14.7 IU/L STANDARD_DEVIATION 5.6 • n=5 Participants	15.0 IU/L STANDARD_DEVIATION 6.4 • n=4 Participants
Detection of malaria parasites by LAMP Yes	59 Participants n=5 Participants	55 Participants n=7 Participants	57 Participants n=5 Participants	171 Participants n=4 Participants
Detection of malaria parasites by LAMP No	47 Participants n=5 Participants	38 Participants n=7 Participants	43 Participants n=5 Participants	128 Participants n=4 Participants
Detection of malaria parasites by LAMP No sample collected	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Delivery

Population: Only women who delivered and had histopathology results were analyzed. 2 women in 3 Dose SP and 1 woman in monthly DP arms completed the study but did not have histopathology results.

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=98 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=88 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=96 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Placental Malaria	49 Participants	30 Participants	26 Participants	—	—

PRIMARY outcome

Timeframe: Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination

Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=106 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=94 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=100 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Incidence of Malaria in Pregnant Women	0.95 events per person years	0.31 events per person years	0 events per person years	—	—

PRIMARY outcome

Timeframe: Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)

Population: All live births

Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age.

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=101 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=44 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=49 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=48 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=52 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Incidence of Malaria in Infants	0.26 Events per person years	0.30 Events per person years	0.00 Events per person years	0.43 Events per person years	0.03 Events per person years

PRIMARY outcome

Timeframe: Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination

Population: All live births

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=85 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=40 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=43 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=39 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=44 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Incidence of Malaria in Infants	0.87 Events per person years	0.88 Events per person years	0.83 Events per person years	1.24 Events per person years	0.64 Events per person years

SECONDARY outcome

Timeframe: Delivery

Prevalence of placental blood samples positive for parasites by microscopy or LAMP

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=96 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=88 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=96 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP Micropscopic assessment of placental blood	5 Participants	3 Participants	0 Participants	—	—
Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP LAMP assessment of placental blood	19 Participants	3 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: At delivery

Population: One observation in the monthly DP arm did not have results for microscopy; this outcome measure tests blood taken from the mother's arm (different from outcome measure 4 which tests blood taken from the placenta)

Prevalence of maternal parasitemia at delivery by microscopy and LAMP

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=102 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=89 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=98 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery Microscopy	5 participants	1 participants	0 participants	—	—
Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery LAMP	25 participants	3 participants	1 participants	—	—

SECONDARY outcome

Timeframe: Delivery

Congenital malformations, spontaneous abortion, LBW (\<2500g), still birth, pre-term delivery

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=102 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=89 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=98 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery	19 Participants	19 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: After first dose of study drugs up to delivery or early termination

Prevalence of routine hemoglobin measurements \< 11 g/dL

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=269 hemoglobin measurements taken every 12wk Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=237 hemoglobin measurements taken every 12wk Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=258 hemoglobin measurements taken every 12wk Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Anemia in Pregnant Women	94 hemoglobin measurements taken every 12wk	72 hemoglobin measurements taken every 12wk	61 hemoglobin measurements taken every 12wk	—	—

SECONDARY outcome

Timeframe: Birth up to 24 months of age or early study termination

Population: All live births

Any treatment for malaria meeting criteria for severe malaria or danger signs

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=101 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=44 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=49 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=48 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=52 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Incidence of Complicated Malaria in Infants	0.022 Events per person years	0.024 Events per person years	0.000 Events per person years	0.035 Events per person years	0.000 Events per person years

SECONDARY outcome

Timeframe: Birth up to 24 months of age or early study termination

Admission to a hospital for pediatric inpatient care for any reason

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=101 Participants Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=44 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=49 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=48 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=52 Participants Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Incidence of Hospital Admissions in Infants	0.043 Events per person years	0.036 Events per person years	0.089 Events per person years	0.082 Events per person years	0.043 Events per person years

SECONDARY outcome

Timeframe: Gestational age between 12-20 weeks (at study entry) up to delivery

Proportion of urgent blood smears positive for gametocytes

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=112 Blood smears Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=86 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=86 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Gametocytemia in Pregnant Women	4 Positive blood smears	1 Positive blood smears	3 Positive blood smears	—	—

SECONDARY outcome

Timeframe: Birth up to 24 months of age or early study termination

Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites.

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=2378 Blood smears Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=1082 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=1155 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=1099 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=1208 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Parasitemia in Infants	59 Positive blood smears	25 Positive blood smears	7 Positive blood smears	52 Positive blood smears	4 Positive blood smears

SECONDARY outcome

Timeframe: After first dose of study drug through delivery or early termination

Detection of malaria parasites by LAMP during pregnancy

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=509 Specimens Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=445 Specimens Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=496 Specimens Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy	206 Positive specimens	74 Positive specimens	26 Positive specimens	—	—

SECONDARY outcome

Timeframe: Birth up to 24 months of age or early study termination

Proportion of routine blood smears positive for gametocytes

Outcome measures

Outcome measures
Measure	Mothers - 3 Dose SP n=2393 Blood smears Women will be given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - 3 Dose DP n=1087 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Mothers - Monthly DP n=1156 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days using weight-based guidelines) every 4 weeks between 8 and 104 weeks of age. 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / 3 Monthly DP Infancy n=1102 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 12 weeks between 8 and 104 weeks of age. Infants randomized to receive DP every 12 weeks will receive placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy 3-monthly dihydroartemisinin-piperaquine (DP) for infants	Monthly DP Pregnancy / Monthly DP Infancy n=1218 Blood smears Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. In addition, placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and placebo, DP and placebo, or two placebos) followed by one pill on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. Infants will be given DP (once a day for 3 consecutive days) every 4 weeks between 8 and 104 weeks of age. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants
Prevalence of Gametocytemia in Infants	7 Positive blood smears	1 Positive blood smears	0 Positive blood smears	4 Positive blood smears	0 Positive blood smears

Adverse Events

Mothers - 3 Dose SP

Serious events: 6 serious events

Other events: 90 other events

Deaths: 0 deaths

Mothers - 3 Dose DP

Serious events: 9 serious events

Other events: 78 other events

Deaths: 0 deaths

Mothers - Monthly DP

Serious events: 3 serious events

Other events: 89 other events

Deaths: 0 deaths

Infants - Monthly DP

Serious events: 9 serious events

Other events: 94 other events

Deaths: 4 deaths

Infants - 3 Monthly DP

Serious events: 15 serious events

Other events: 183 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Mothers - 3 Dose SP n=106 participants at risk Women were given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, DP placebo was used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and DP placebo) followed by one pill on days 2 and 3 (DP placebo).	Mothers - 3 Dose DP n=94 participants at risk Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, SP and DP placebos were used to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP placebo).	Mothers - Monthly DP n=100 participants at risk Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) monthly. In addition, SP placebo to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP).	Infants - Monthly DP n=100 participants at risk DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines.	Infants - 3 Monthly DP n=191 participants at risk DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines. Infants received placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.
Blood and lymphatic system disorders Anemia	1.9% 2/106 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.1% 1/94 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.0% 2/100 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	3.0% 3/100 • Number of events 3 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Congenital, familial and genetic disorders Congenital Anomaly	1.9% 2/106 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	4.3% 4/94 • Number of events 4 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Pregnancy, puerperium and perinatal conditions Stillbirth	0.94% 1/106 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.1% 1/94 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Pregnancy, puerperium and perinatal conditions Threatened Abortion	0.94% 1/106 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Pregnancy, puerperium and perinatal conditions Retained products of conception	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.1% 1/94 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Blood and lymphatic system disorders Preeclampsia	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Renal and urinary disorders Pyelonephritis	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.1% 1/94 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.1% 1/94 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.6% 3/191 • Number of events 3 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Elevated temperature	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 2/191 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Renal and urinary disorders Elevated Alanine Aminotransferase	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.0% 2/100 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Nervous system disorders Seizure	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 2/191 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Psychiatric disorders Altered Mental State	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Skin and subcutaneous tissue disorders Burns	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Immune system disorders Neutropenia	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Malnutrition	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Dehydration	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.52% 1/191 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Gastrointestinal disorders Diarrhea	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 2/191 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009

Other adverse events

Other adverse events
Measure	Mothers - 3 Dose SP n=106 participants at risk Women were given SP (3 full strength tabs, 500 mg/25 mg) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, DP placebo was used to mimic the identical dosing strategy such that every 4 weeks women will receive two pills on day 1 (SP and DP placebo) followed by one pill on days 2 and 3 (DP placebo).	Mothers - 3 Dose DP n=94 participants at risk Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) 3 times during pregnancy at 20, 28, and 36 weeks gestational age. In addition, SP and DP placebos were used to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP placebo).	Mothers - Monthly DP n=100 participants at risk Women were given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) monthly. In addition, SP placebo to mimic the identical dosing strategy as other arms such that every 4 weeks women will receive two pills on day 1 (DP and SP placebo) followed by one pill on days 2 and 3 (DP).	Infants - Monthly DP n=100 participants at risk DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines.	Infants - 3 Monthly DP n=191 participants at risk DP half-strength tablets given once a day for 3 consecutive days according to weight based guidelines. Infants received placebo mimicking the dosing of DP every 4 weeks when they are not receiving study drug.
General disorders Abdominal pain	69.8% 74/106 • Number of events 172 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	61.7% 58/94 • Number of events 122 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	73.0% 73/100 • Number of events 132 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Cough	51.9% 55/106 • Number of events 94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	51.1% 48/94 • Number of events 71 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	57.0% 57/100 • Number of events 77 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	94.0% 94/100 • Number of events 1127 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	95.8% 183/191 • Number of events 2230 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Headache	52.8% 56/106 • Number of events 90 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	47.9% 45/94 • Number of events 70 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	55.0% 55/100 • Number of events 78 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Chills	18.9% 20/106 • Number of events 21 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	13.8% 13/94 • Number of events 14 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	11.0% 11/100 • Number of events 12 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Gastrointestinal disorders Diarrhea	9.4% 10/106 • Number of events 12 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	8.5% 8/94 • Number of events 10 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	10.0% 10/100 • Number of events 13 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	87.0% 87/100 • Number of events 470 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	88.0% 168/191 • Number of events 938 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Malaise	14.2% 15/106 • Number of events 16 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	9.6% 9/94 • Number of events 9 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	6.0% 6/100 • Number of events 8 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	10.0% 10/100 • Number of events 10 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	13.1% 25/191 • Number of events 28 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Dysphagia	8.5% 9/106 • Number of events 9 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.1% 2/94 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	13.0% 13/100 • Number of events 14 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Gastrointestinal disorders Vomiting	6.6% 7/106 • Number of events 8 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	8.5% 8/94 • Number of events 8 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	8.0% 8/100 • Number of events 8 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	58.0% 58/100 • Number of events 114 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	61.3% 117/191 • Number of events 191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Gastrointestinal disorders Nausea	1.9% 2/106 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	4.3% 4/94 • Number of events 4 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.0% 2/100 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Renal and urinary disorders Urinary tract infection	2.8% 3/106 • Number of events 3 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.1% 2/94 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.0% 2/100 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
General disorders Anorexia	1.9% 2/106 • Number of events 2 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	4.0% 4/100 • Number of events 4 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	16.0% 16/100 • Number of events 18 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	22.5% 43/191 • Number of events 191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Blood and lymphatic system disorders Anemia	8.5% 9/106 • Number of events 10 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	2.1% 2/94 • Number of events 3 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	4.0% 4/100 • Number of events 4 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Blood and lymphatic system disorders Thrombocytopenia	0.94% 1/106 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Blood and lymphatic system disorders Hypotension	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	1.0% 1/100 • Number of events 1 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Skin and subcutaneous tissue disorders Rash	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	29.0% 29/100 • Number of events 43 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	29.3% 56/191 • Number of events 191 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009
Eye disorders Conjunctivitis	0.00% 0/106 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/94 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	0.00% 0/100 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	27.0% 27/100 • Number of events 34 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009	25.7% 49/191 • Number of events 62 • For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs. National Institutes of Health, Division of AIDS (DAIDS) Table for Grading the Severity of ADULT AND PEDIATRIC Adverse Events Version 1.0, December, 2004; clarification AUGUST 2009

Additional Information

Dr. Grant Dorsey

UCSF

Phone: 415-206-4680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place