Trial Outcomes & Findings for Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy (NCT NCT03208231)

NCT ID: NCT03208231

Last Updated: 2023-05-24

Results Overview

Includes reactogenicity outcomes, abnormal laboratory test results, signs, symptoms, and diagnoses. Adverse event severity grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Two-sided exact 95% Clopper-Pearson confidence intervals were calculated.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From Week 0 to Week 14

Results posted on

2023-05-24

Participant Flow

61 infants were enrolled at 7 sites in 4 countries (Botswana, Malawi, Zimbabwe and Brazil) between August 6, 2018 and March 11, 2020.

Infants were randomized equally to the two study arms. Randomization was stratified by whether their initial combination antiretroviral (cART) regimen included an integrase inhibitor.

Participant milestones

Participant milestones
Measure	VRC01 (Arm 1) Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Overall Study STARTED	30	31
Overall Study Evaluable	30	30
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	VRC01 (Arm 1) Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Overall Study Death	1	2
Overall Study Moved and unable to get to clinic	1	0
Overall Study Unwilling to adhere to study requirements	0	1

Baseline Characteristics

One infant in No-VRC01 arm did not return to the clinic after entry and their entry HIV-1 DNA was not included.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VRC01 (Arm 1) n=30 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) n=31 Participants Infants did not receive VRC01. All infants on cART.	Total n=61 Participants Total of all reporting groups
Age, Continuous	72 Days n=30 Participants	73 Days n=31 Participants	73 Days n=61 Participants
Sex: Female, Male Female	14 Participants n=30 Participants	21 Participants n=31 Participants	35 Participants n=61 Participants
Sex: Female, Male Male	16 Participants n=30 Participants	10 Participants n=31 Participants	26 Participants n=61 Participants
Race/Ethnicity, Customized Race/ethnicity · Black Non-Hispanic	25 Participants n=30 Participants	26 Participants n=31 Participants	51 Participants n=61 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic (Regardless of Race)	5 Participants n=30 Participants	5 Participants n=31 Participants	10 Participants n=61 Participants
Region of enrollment Botswana	0 Participants n=30 Participants	7 Participants n=31 Participants	7 Participants n=61 Participants
Region of enrollment Brazil	3 Participants n=30 Participants	3 Participants n=31 Participants	6 Participants n=61 Participants
Region of enrollment Malawi	25 Participants n=30 Participants	17 Participants n=31 Participants	42 Participants n=61 Participants
Region of enrollment Zimbabwe	2 Participants n=30 Participants	4 Participants n=31 Participants	6 Participants n=61 Participants
Days on antiretrovirals prior to study entry	8 Days n=30 Participants	6 Days n=31 Participants	7 Days n=61 Participants
Days on antiretrovirals prior to study entry 0	1 Participants n=30 Participants	5 Participants n=31 Participants	6 Participants n=61 Participants
Days on antiretrovirals prior to study entry 1-7	11 Participants n=30 Participants	15 Participants n=31 Participants	26 Participants n=61 Participants
Days on antiretrovirals prior to study entry >7	18 Participants n=30 Participants	11 Participants n=31 Participants	29 Participants n=61 Participants
HIV-1 RNA (copies/ml) <1000 copies/ml	2 Participants n=30 Participants	3 Participants n=31 Participants	5 Participants n=61 Participants
HIV-1 RNA (copies/ml) 1000 - < 10,000 copies/ml	10 Participants n=30 Participants	8 Participants n=31 Participants	18 Participants n=61 Participants
HIV-1 RNA (copies/ml) 10,000 - < 100,000 copies/ml	11 Participants n=30 Participants	10 Participants n=31 Participants	21 Participants n=61 Participants
HIV-1 RNA (copies/ml) >= 100,000 copies/ml	7 Participants n=30 Participants	10 Participants n=31 Participants	17 Participants n=61 Participants
HIV-1 RNA (copies/ml)	12,552 copies/ml n=30 Participants	22,625 copies/ml n=31 Participants	16,566 copies/ml n=61 Participants
HIV-1 DNA (log10 copies/million PBMCs)	3.12 log10 copies/million PBMCs n=30 Participants • One infant in No-VRC01 arm did not return to the clinic after entry and their entry HIV-1 DNA was not included.	3.16 log10 copies/million PBMCs n=30 Participants • One infant in No-VRC01 arm did not return to the clinic after entry and their entry HIV-1 DNA was not included.	3.15 log10 copies/million PBMCs n=60 Participants • One infant in No-VRC01 arm did not return to the clinic after entry and their entry HIV-1 DNA was not included.

PRIMARY outcome

Timeframe: From Week 0 to Week 14

Population: One infant in the No-VRC01 arm did not return to clinic after Week 0 and is not included in the analysis population

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=30 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) n=30 Participants Infants did not receive VRC01. All infants on cART.
Percentage of Infants Experiencing at Least One Grade 3 or Higher Adverse Event (AE)	40.0 Percentage of participants Interval 22.7 to 59.4	46.7 Percentage of participants Interval 28.3 to 65.7

PRIMARY outcome

Timeframe: Week 0 and Week 14

Population: One infant in No-VRC01 arm did not return to clinic after week 0 and is not included in analysis population

Mean changes (Week 14 - Week 0) were calculated on log10-transformed HIV-1 DNA concentration. Values below the assay detection limit were set to half the lower assay limit of 4.09 copies/million PBMCs. Values above the detection limit were set to the upper limit of 10,000 copies/million PBMCs.

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=30 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) n=30 Participants Infants did not receive VRC01. All infants on cART.
Change in HIV-1 DNA Concentration in Peripheral Blood Mononuclear Cells (PBMCs) From Week 0 to Week 14	-0.41 log10 copies/million PBMCs Interval -0.56 to -0.3	-0.53 log10 copies/million PBMCs Interval -0.7 to -0.33

SECONDARY outcome

Timeframe: Weeks 2, 6, 10, 14, and 16

Population: One infant had no PK measurements run as sample sent to incorrect location for testing.

Median (mcg/ml) pre-dose VRC01 concentrations in the plasma (VRC01 Arm only)

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=29 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Median Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 2	109.4 mcg/ml Interval 91.3 to 132.1	—
Median Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 6	79.5 mcg/ml Interval 52.9 to 114.5	—
Median Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 10	96.5 mcg/ml Interval 38.5 to 113.3	—
Median Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 14	82.3 mcg/ml Interval 27.0 to 105.9	—
Median Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 16	53.2 mcg/ml Interval 15.5 to 78.6	—

SECONDARY outcome

Timeframe: Weeks 2, 6, 10, 14, and 16

Population: One infant had no PK measurements run as sample sent to incorrect location for testing.

Geometric mean (mcg/ml) of pre-dose VRC01 concentrations with 90% confidence intervals

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=29 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Geometric Mean of Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 10	57.5 mcg/ml Interval 35.7 to 92.5	—
Geometric Mean of Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 14	47.6 mcg/ml Interval 29.0 to 78.1	—
Geometric Mean of Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 16	26.7 mcg/ml Interval 14.8 to 48.4	—
Geometric Mean of Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 2	104.2 mcg/ml Interval 90.1 to 120.4	—
Geometric Mean of Pre-dose VRC01 Concentrations in the Plasma (VRC01 Arm Only) Week 6	64.7 mcg/ml Interval 45.8 to 91.4	—

SECONDARY outcome

Timeframe: Weeks 2, 6, 10, 14, 16

Population: One infant had no PK measurements run as sample sent to incorrect location for testing.

Percentage of infants with pre-dose VRC01 concentrations \>= 20 mcg/ml in the plasma (VRC01 Arm only)

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=29 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Percentage of Infants With Pre-dose VRC01 Concentrations >= 20 mcg/ml in the Plasma (VRC01 Arm Only) Week 2	28 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 20 mcg/ml in the Plasma (VRC01 Arm Only) Week 6	25 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 20 mcg/ml in the Plasma (VRC01 Arm Only) Week 10	25 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 20 mcg/ml in the Plasma (VRC01 Arm Only) Week 14	24 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 20 mcg/ml in the Plasma (VRC01 Arm Only) Week 16	18 Participants	—

SECONDARY outcome

Timeframe: Weeks 2, 6, 10, 14, 16

Population: One infant had no PK measurements run as sample sent to incorrect location for testing.

Percentage of infants with pre-dose VRC01 concentrations \>= 50 mcg/ml in the plasma (VRC01 Arm only)

Outcome measures

Outcome measures
Measure	VRC01 (Arm 1) n=29 Participants Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 (Arm 2) Infants did not receive VRC01. All infants on cART.
Percentage of Infants With Pre-dose VRC01 Concentrations >= 50 mcg/ml in the Plasma (VRC01 Arm Only) Week 2	27 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 50 mcg/ml in the Plasma (VRC01 Arm Only) Week 6	21 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 50 mcg/ml in the Plasma (VRC01 Arm Only) Week 10	20 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 50 mcg/ml in the Plasma (VRC01 Arm Only) Week 14	18 Participants	—
Percentage of Infants With Pre-dose VRC01 Concentrations >= 50 mcg/ml in the Plasma (VRC01 Arm Only) Week 16	15 Participants	—

Adverse Events

VRC01

Serious events: 7 serious events

Other events: 30 other events

Deaths: 1 deaths

No-VRC01

Serious events: 11 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

IMPAACT Clinicaltrials.gov Coordinator

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	VRC01 n=30 participants at risk Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 n=30 participants at risk Infants did not receive VRC01. All infants on cART.
Infections and infestations Arthritis bacterial	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Bacterial pyelonephritis	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Bronchiolitis	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Gastroenteritis	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pneumonia bacterial	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pulmonary tuberculosis	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Malnutrition	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Otitis media	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Sepsis	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Blood and lymphatic system disorders Anaemia	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Gastrointestinal disorders Infantile vomiting	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Bacterial sepsis	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Escherichia pyelonephritis	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Escherichia sepsis	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Plasmodium falciparum infection	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Salmonella sepsis	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Haemoglobin decreased	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Neutrophil count decreased	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Platelet count decreased	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Dehydration	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.

Other adverse events
Measure	VRC01 n=30 participants at risk Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10. All infants on cART.	No-VRC01 n=30 participants at risk Infants did not receive VRC01. All infants on cART.
Blood and lymphatic system disorders Anaemia	50.0% 15/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	40.0% 12/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Blood and lymphatic system disorders Lymphadenopathy	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Blood and lymphatic system disorders Neutropenia	20.0% 6/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Ear and labyrinth disorders Ear pain	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Ear and labyrinth disorders Otorrhoea	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Eye disorders Eye discharge	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Eye disorders Lid sulcus deepened	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Eye disorders Ocular hyperaemia	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Gastrointestinal disorders Diarrhoea	43.3% 13/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	33.3% 10/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Gastrointestinal disorders Infantile vomiting	20.0% 6/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	30.0% 9/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Gastrointestinal disorders Vomiting	20.0% 6/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
General disorders Peripheral swelling	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
General disorders Pyrexia	33.3% 10/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	30.0% 9/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
General disorders Vaccination site induration	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Acarodermatitis	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Conjunctivitis	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Folliculitis	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Gastroenteritis	20.0% 6/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	23.3% 7/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Oral candidiasis	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Otitis media acute	16.7% 5/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pharyngitis	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pneumonia bacterial	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Pyuria	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Upper respiratory tract infection	30.0% 9/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	16.7% 5/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Infections and infestations Urinary tract infection	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Alanine aminotransferase increased	20.0% 6/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Aspartate aminotransferase increased	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Blood alkaline phosphatase increased	16.7% 5/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	30.0% 9/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Blood creatinine increased	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Blood potassium increased	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Breath sounds abnormal	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Haemoglobin decreased	90.0% 27/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	93.3% 28/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Neutrophil count decreased	70.0% 21/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	50.0% 15/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Investigations Platelet count decreased	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Decreased appetite	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Dehydration	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	13.3% 4/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Poor feeding infant	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Metabolism and nutrition disorders Underweight	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	3.3% 1/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Nervous system disorders Infant irritability	10.0% 3/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.
Psychiatric disorders Irritability	6.7% 2/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.	0.00% 0/30 • From study entry to study completion at Week 48 or premature study discontinuation. Complete blood count and selected chemistries assessed at screening, Weeks 1, 3, 7, 11, 14, 20, and 24. Signs, symptoms and diagnoses were recorded up to Week 16 if \>= Grade 1 and after Week 16 if \>= Grade 2. AE severity was graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 except for axillary measured fever and injection site pain/tenderness, which were graded according to study-specific criteria in Section 7.3.3 of the Protocol.