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Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

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ClinicalTrials.gov Identifier: NCT01828073
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : May 15, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Intervention Drug: Raltegravir
Enrollment 40
Recruitment Details

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.
Pre-assignment Details  
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 22 18
Completed 21 16
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 22 18 40
Hide Baseline Analysis Population Description
All infants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 18 participants 40 participants
<=18 years
22
 100.0%
18
 100.0%
40
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 22 participants 18 participants 40 participants
Enrolled prior to birth
22
 100.0%
0
   0.0%
22
  55.0%
Enrolled after birth
0
   0.0%
18
 100.0%
18
  45.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 18 participants 40 participants
Female
6
  27.3%
12
  66.7%
18
  45.0%
Male
16
  72.7%
6
  33.3%
22
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 18 participants 40 participants
Hispanic or Latino
8
  36.4%
9
  50.0%
17
  42.5%
Not Hispanic or Latino
13
  59.1%
9
  50.0%
22
  55.0%
Unknown or Not Reported
1
   4.5%
0
   0.0%
1
   2.5%
Birth Weight (g)  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 22 participants 18 participants 40 participants
1500 - <2000 g
0
   0.0%
7
  38.9%
7
  17.5%
2000 - 2500 g
1
   4.5%
11
  61.1%
12
  30.0%
>2500 g
21
  95.5%
0
   0.0%
21
  52.5%
1.Primary Outcome
Title PK Parameter: Neonatal RAL Elimination Half-life (T1/2)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: Hours
26.6
(9.3 to 184)
24.4
(10.1 to 83)
2.Primary Outcome
Title Ratio of Cord Blood to Maternal Blood RAL Concentrations
Hide Description Ratio of the neonatal cord blood RAL concentration to the mother's plasma RAL concentration at birth
Time Frame Maternal blood samples were scheduled to be collected within 1 hour after delivery and cord blood sample were collected immediately after cord was clamped
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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. The group also includes the mothers of these infants.

Raltegravir: No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.

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. The group also includes the mothers of these infants.

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 Number of Participants Analyzed 19 2
Median (Full Range)
Unit of Measure: ratio
1.48
(0.32 to 4.33)
2.62
(1.04 to 4.20)
3.Primary Outcome
Title Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death)
Hide Description

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.
Time Frame Assessed at entry through Week 20 for Cohort 1 infants and through Week 6 for Cohort 2 infants.
Hide Outcome Measure Data
Hide Analysis Population Description
All infants.
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 18
Measure Type: Count of Participants
Unit of Measure: Participants
7
  31.8%
9
  50.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL
Comments Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson Confidence Interval (CI)
Estimated Value 31.82
Confidence Interval (2-Sided) 90%
16.00 to 51.50
Estimation Comments With the small sample size, the CI estimate tend to be wide.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Comments Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson Confidence Interval (CI)
Estimated Value 50.00
Confidence Interval (2-Sided) 90%
29.10 to 70.90
Estimation Comments With the small sample size, the CI estimate tend to be wide.
4.Primary Outcome
Title Infant Total Bilirubin
Hide Description Total bilirubin measured from infant blood specimens.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Infants with total bilirubin results
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 18
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Visit 1 Number Analyzed 21 participants 13 participants
3.7
(3.0 to 4.5)
6.6
(5.9 to 8.1)
Visit 2 Number Analyzed 19 participants 13 participants
5.7
(3.8 to 7.0)
10.7
(8.4 to 11.3)
Visit 3 Number Analyzed 19 participants 18 participants
2.7
(0.8 to 5.2)
4.6
(2.2 to 9.3)
5.Primary Outcome
Title Infant Direct Bilirubin
Hide Description Direct bilirubin measured from infant blood specimens.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Infants with Direct Bilirubin results
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 18
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Visit 1 Number Analyzed 18 participants 16 participants
0.3
(0.2 to 0.4)
0.5
(0.3 to 0.7)
Visit 2 Number Analyzed 18 participants 16 participants
0.4
(0.3 to 0.5)
0.4
(0.3 to 0.6)
Visit 3 Number Analyzed 19 participants 18 participants
0.3
(0.2 to 0.4)
0.5
(0.4 to 0.6)
6.Primary Outcome
Title Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice
Hide Description Assessment if infant received exchange transfusion, Phototherapy, or other treatment to reduce bilirubin or for jaundice
Time Frame Assessed from entry through around week 1 after birth
Hide Outcome Measure Data
Hide Analysis Population Description
All infants.
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 18
Measure Type: Count of Participants
Unit of Measure: Participants
Exchange transfusion therapy
0
   0.0%
0
   0.0%
Phototherapy
1
   4.5%
4
  22.2%
Other treatment
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Infants with data on UGT1A1 genotype and RAL half-life (T1/2)
Arm/Group Title Cohort 1 Infants With UGT1A1 Mutation Cohort 1 Infants With Normal UGT1A1 Phenotype Cohort 2 Infants With UGT1A1 Mutation Cohort 2 Infants With Normal UGT1A1 Phenotype
Hide Arm/Group Description:
Cohort 1 (full term) infants with the presence of UGT1A1 *28/*28 genetic variant
Cohort 1 (full term) infants with the absence of UGT1A1 *28/*28 genetic variant
Cohort 2 (LBW) infants with the presence of UGT1A1 *28/*28 genetic variant
Cohort 2 (LBW) infants with the absence of the UGT1A1 *28/*28 genetic variant
Overall Number of Participants Analyzed 8 6 9 7
Median (Inter-Quartile Range)
Unit of Measure: Hours
40.85
(13.55 to 82.05)
32.75
(23.90 to 69.20)
21.1
(18.4 to 26.3)
39.7
(11.5 to 51.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1 Infants With UGT1A1 Mutation, Cohort 1 Infants With Normal UGT1A1 Phenotype
Comments To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments The study was not powered to do the comparison. This was an exploratory analysis.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2 Infants With UGT1A1 Mutation, Cohort 2 Infants With Normal UGT1A1 Phenotype
Comments To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments The study was not powered to do the comparison. This was an exploratory analysis.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Birth through 20 weeks and 6 weeks for Cohort 1 and Cohort 2, respectively.
Adverse Event Reporting Description 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.
 
Arm/Group Title Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   5/18 (27.78%) 
Congenital, familial and genetic disorders     
Congenital syphilis † 1  0/22 (0.00%)  1/18 (5.56%) 
Hypospadias † 1  0/22 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Abdominal distension † 1  0/22 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Pneumonia † 1  0/22 (0.00%)  1/18 (5.56%) 
Surgical and medical procedures     
Infection prophylaxis † 1  0/22 (0.00%)  1/18 (5.56%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL Cohort 2: LBW Infants Exposed in Utero to Maternal RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   21/22 (95.45%)   16/18 (88.89%) 
Cardiac disorders     
Bradycardia neonatal † 1  0/22 (0.00%)  1/18 (5.56%) 
Congenital, familial and genetic disorders     
Atrial septal defect † 1  0/22 (0.00%)  1/18 (5.56%) 
Congenital cardiovascular anomaly † 1  0/22 (0.00%)  1/18 (5.56%) 
Congenital laryngeal stridor † 1  0/22 (0.00%)  1/18 (5.56%) 
Congenital umbilical hernia † 1  1/22 (4.55%)  2/18 (11.11%) 
Cryptorchism † 1  0/22 (0.00%)  1/18 (5.56%) 
Eye disorders     
Conjunctival haemorrhage † 1  0/22 (0.00%)  1/18 (5.56%) 
Conjunctival pallor † 1  0/22 (0.00%)  2/18 (11.11%) 
Eyelid oedema † 1  0/22 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Constipation † 1  2/22 (9.09%)  0/18 (0.00%) 
Perianal erythema † 1  0/22 (0.00%)  1/18 (5.56%) 
Vomiting † 1  2/22 (9.09%)  2/18 (11.11%) 
General disorders     
Decreased activity † 1  0/22 (0.00%)  1/18 (5.56%) 
Pyrexia † 1  4/22 (18.18%)  2/18 (11.11%) 
Hepatobiliary disorders     
Hepatomegaly † 1  0/22 (0.00%)  1/18 (5.56%) 
Hyperbilirubinaemia neonatal † 1  0/22 (0.00%)  1/18 (5.56%) 
Jaundice † 1  0/22 (0.00%)  4/18 (22.22%) 
Infections and infestations     
Bacterial sepsis † 1  0/22 (0.00%)  2/18 (11.11%) 
Oral candidiasis † 1  2/22 (9.09%)  0/18 (0.00%) 
Pneumonia bacterial † 1  1/22 (4.55%)  1/18 (5.56%) 
Upper respiratory tract infection † 1  0/22 (0.00%)  1/18 (5.56%) 
Investigations     
Aspartate aminotransferase increased † 1  15/22 (68.18%)  3/18 (16.67%) 
Blood bilirubin increased † 1  2/22 (9.09%)  1/18 (5.56%) 
Blood creatinine abnormal † 1  0/22 (0.00%)  1/18 (5.56%) 
Blood creatinine increased † 1  2/22 (9.09%)  5/18 (27.78%) 
Breath sounds abnormal † 1  2/22 (9.09%)  0/18 (0.00%) 
Haemoglobin abnormal † 1  1/22 (4.55%)  1/18 (5.56%) 
Haemoglobin decreased † 1  8/22 (36.36%)  5/18 (27.78%) 
Neutrophil count abnormal † 1  0/22 (0.00%)  2/18 (11.11%) 
Neutrophil count decreased † 1  5/22 (22.73%)  6/18 (33.33%) 
Metabolism and nutrition disorders     
Feeding disorder † 1  0/22 (0.00%)  1/18 (5.56%) 
Hyperkalaemia † 1  0/22 (0.00%)  1/18 (5.56%) 
Hypoglycaemia neonatal † 1  1/22 (4.55%)  1/18 (5.56%) 
Malnutrition † 1  0/22 (0.00%)  1/18 (5.56%) 
Poor feeding infant † 1  0/22 (0.00%)  1/18 (5.56%) 
Pregnancy, puerperium and perinatal conditions     
Cephalhaematoma † 1  2/22 (9.09%)  0/18 (0.00%) 
Jaundice neonatal † 1  6/22 (27.27%)  4/18 (22.22%) 
Psychiatric disorders     
Irritability † 1  3/22 (13.64%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  2/22 (9.09%)  1/18 (5.56%) 
Dyspnoea † 1  3/22 (13.64%)  1/18 (5.56%) 
Grunting † 1  0/22 (0.00%)  1/18 (5.56%) 
Nasal congestion † 1  3/22 (13.64%)  0/18 (0.00%) 
Neonatal hypoxia † 1  0/22 (0.00%)  1/18 (5.56%) 
Neonatal respiratory distress † 1  0/22 (0.00%)  1/18 (5.56%) 
Neonatal respiratory distress syndrome † 1  0/22 (0.00%)  5/18 (27.78%) 
Neonatal tachypnoea † 1  1/22 (4.55%)  2/18 (11.11%) 
Respiratory distress † 1  0/22 (0.00%)  1/18 (5.56%) 
Rhinorrhoea † 1  2/22 (9.09%)  0/18 (0.00%) 
Snoring † 1  0/22 (0.00%)  1/18 (5.56%) 
Use of accessory respiratory muscles † 1  1/22 (4.55%)  1/18 (5.56%) 
Wheezing † 1  2/22 (9.09%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema † 1  1/22 (4.55%)  1/18 (5.56%) 
Erythema toxicum neonatorum † 1  0/22 (0.00%)  1/18 (5.56%) 
Papule † 1  1/22 (4.55%)  1/18 (5.56%) 
Rash † 1  2/22 (9.09%)  0/18 (0.00%) 
Seborrhoeic dermatitis † 1  2/22 (9.09%)  0/18 (0.00%) 
Skin exfoliation † 1  1/22 (4.55%)  1/18 (5.56%) 
Skin swelling † 1  0/22 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Pallor † 1  1/22 (4.55%)  2/18 (11.11%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
EMail: mallen@fhi360.org
Publications:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01828073    
Other Study ID Numbers: P1097
11790 ( Registry Identifier: DAIDS ES )
IMPAACT P1097
First Submitted: April 5, 2013
First Posted: April 10, 2013
Results First Submitted: April 23, 2019
Results First Posted: May 15, 2019
Last Update Posted: February 18, 2020