Trial Outcomes & Findings for Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants (NCT NCT01828073)

Last Updated: 2021-11-08

Results Overview

Time required for neonatal plasma concentration to decrease by one-half. T1/2 was estimated using the terminal 3 concentration-time points for each infant when available.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

Infant blood specimens were collected at 1-5, 8-14, 18-24, and 30-36 hours after birth for Cohort 1; and at 1-6, 12-24, 36-48, 72-84, and 108-132 hours after birth, and on day 7-14 for Cohort 2.

Results posted on

2021-11-08

Participant Flow

Cohort 1 participants were enrolled from 11 sites in the USA. Enrollment period was from May 2011 through September 2012. Cohort 2 participants were enrolled from 4 sites in Brazil, 1 site in South Africa, 1 site in Tanzania, 1 site in Thailand, and 3 sites in the USA. Enrollment period was from January 2015 through March 2018.

Participant milestones

Participant milestones
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs was given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.
Overall Study STARTED	22	18
Overall Study COMPLETED	21	16
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs was given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Enrolled prior to birth	22 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants
Age, Customized Enrolled after birth	0 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Birth Weight (g) 1500 - <2000 g	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Birth Weight (g) 2000 - 2500 g	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Birth Weight (g) >2500 g	21 Participants n=5 Participants	0 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Infant blood specimens were collected at 1-5, 8-14, 18-24, and 30-36 hours after birth for Cohort 1; and at 1-6, 12-24, 36-48, 72-84, and 108-132 hours after birth, and on day 7-14 for Cohort 2.

Population: Infants with RAL concentration (conc) for whom T1/2 could be calculated. Excluded (i) 5 Cohort 1 infants: 2 had no data, 3 had data but could not calculate T1/2 (terminal RAL conc below level of quantification (BLQ), higher RAL conc at later collection time); and (ii) 1 Cohort 2 infants:1 had terminal RAL conc BLQ.

Time required for neonatal plasma concentration to decrease by one-half. T1/2 was estimated using the terminal 3 concentration-time points for each infant when available.

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=17 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=17 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
PK Parameter: Neonatal RAL Elimination Half-life (T1/2)	26.6 Hours Interval 9.3 to 184.0	24.4 Hours Interval 10.1 to 83.0	—	—

PRIMARY outcome

Timeframe: Maternal blood samples were scheduled to be collected within 1 hour after delivery and cord blood sample were collected immediately after cord was clamped

Population: Mother-Infant (M-I) pairs with maternal blood and cord blood samples. Excluded were (i) 3 Cohort 1 M-I pairs with neither cord blood nor maternal blood samples; and (ii) 16 Cohort 2 M-I pairs: 5 had neither cord blood nor maternal blood specimens, 11 had no cord blood specimen.

Ratio of the neonatal cord blood RAL concentration to the mother's plasma RAL concentration at birth

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=19 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=2 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Ratio of Cord Blood to Maternal Blood RAL Concentrations	1.48 ratio Interval 0.32 to 4.33	2.62 ratio Interval 1.04 to 4.2	—	—

PRIMARY outcome

Timeframe: Assessed at entry through Week 20 for Cohort 1 infants and through Week 6 for Cohort 2 infants.

Population: All infants.

An infant was said to have met the composite safety endpoint if any of the following was observed: * adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table * adverse birth outcomes including stillbirth and low birth weight (LBW), or * death. Stillbirth could only be observed on infants enrolled prior to delivery. Cohort 2 enrolled LBW infants and prematurity and growth restriction which were highly linked to LBW were considered as baseline events and not AEs or adverse birth outcome for Cohort 2 infants.

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death)	7 Participants	9 Participants	—	—

PRIMARY outcome

Timeframe: Measured at 8-14 hours (Visit 1), 30-36 hours (Visit 2) and 1-2 weeks (Visit 3) after birth for Cohort 1; and at 36-48 hours (Visit 1), 72-84 hours (Visit 2) and 1 week (Visit 3)after birth for Cohort 2.

Population: Infants with total bilirubin results

Total bilirubin measured from infant blood specimens.

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Infant Total Bilirubin Visit 1	3.7 mg/dL Interval 3.0 to 4.5	6.6 mg/dL Interval 5.9 to 8.1	—	—
Infant Total Bilirubin Visit 2	5.7 mg/dL Interval 3.8 to 7.0	10.7 mg/dL Interval 8.4 to 11.3	—	—
Infant Total Bilirubin Visit 3	2.7 mg/dL Interval 0.8 to 5.2	4.6 mg/dL Interval 2.2 to 9.3	—	—

PRIMARY outcome

Population: Infants with Direct Bilirubin results

Direct bilirubin measured from infant blood specimens.

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Infant Direct Bilirubin Visit 1	0.3 mg/dL Interval 0.2 to 0.4	0.5 mg/dL Interval 0.3 to 0.7	—	—
Infant Direct Bilirubin Visit 3	0.3 mg/dL Interval 0.2 to 0.4	0.5 mg/dL Interval 0.4 to 0.6	—	—
Infant Direct Bilirubin Visit 2	0.4 mg/dL Interval 0.3 to 0.5	0.4 mg/dL Interval 0.3 to 0.6	—	—

PRIMARY outcome

Timeframe: Assessed from entry through around week 1 after birth

Population: All infants.

Assessment if infant received exchange transfusion, Phototherapy, or other treatment to reduce bilirubin or for jaundice

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice Exchange transfusion therapy	0 Participants	0 Participants	—	—
Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice Phototherapy	1 Participants	4 Participants	—	—
Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice Other treatment	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Genotype was assessed close to birth and if this is not possible at 1-2 wks after birth. PK samples were collected at 1-5, 8-14, 18-24 and 30-36 hrs after birth for Cohort 1; 1-6, 12-24, 36-48, 72-84 and 108-132 hrs after birth, and day 7-14 for Cohort 2.

Population: Infants with data on UGT1A1 genotype and RAL half-life (T1/2)

Neonatal RAL elimination was the time required for neonatal plasma concentration to decrease by one-half. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians(i.e. genotyping was optional) . The goal of the genotypic analysis is to determine if certain polymorphisms, particularly those with the UGT1A1\*28/\*28 genotype have slower RAL elimination than those with the UGT1A1\*1/\*1 genotype.

Outcome measures

Outcome measures
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=8 Participants Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=6 Participants Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2 Infants With UGT1A1 Mutation n=9 Participants Cohort 2 (LBW) infants with the presence of UGT1A1 \28/\28 genetic variant	Cohort 2 Infants With Normal UGT1A1 Phenotype n=7 Participants Cohort 2 (LBW) infants with the absence of the UGT1A1 \28/\28 genetic variant
Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation)	40.85 Hours Interval 13.55 to 82.05	32.75 Hours Interval 23.9 to 69.2	21.1 Hours Interval 18.4 to 26.3	39.7 Hours Interval 11.5 to 51.5

Adverse Events

Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort 2: LBW Infants Exposed in Utero to Maternal RAL

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL n=22 participants at risk Infants, who were expected to be ≥2000 grams at birth (i.e. full-term), born to women with HIV-1 infection who received RAL 400 mg twice daily for at least two weeks prior to delivery and continued to receive ARVs during labor. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.	Cohort 2: LBW Infants Exposed in Utero to Maternal RAL n=18 participants at risk Infants, who were expected to be ≤2500 grams at birth (i.e. LBW), born to women with HIV-1 infection who received at least one dose of RAL 400 mg within 2 to 24 hours prior to delivery. Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/22 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.6% 1/18 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Congenital, familial and genetic disorders Hypospadias	0.00% 0/22 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.6% 1/18 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Gastrointestinal disorders Abdominal distension	0.00% 0/22 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.6% 1/18 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Pneumonia	0.00% 0/22 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.6% 1/18 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Surgical and medical procedures Infection prophylaxis	0.00% 0/22 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	5.6% 1/18 • Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively. All Adverse Events (AEs) including diagnoses, signs/symptoms and abnormal laboratory test results mentioned in the "Study Description". LBW is an eligibility criterion for Cohort 2. Prematurity and growth restrictions, which were AEs linked with LBW, were defined in the protocol as baseline events for Cohort 2 infants and were excluded from the "Serious Adverse Events" and "Other Adverse Events tables" for Cohort 2.The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Publication restrictions are in place

Restriction type: OTHER