Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504841
Recruitment Status : Active, not recruiting
First Posted : January 5, 2012
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Etravirine (ETR)
Enrollment 26
Recruitment Details The first participant was enrolled March 2013, and the final participant was enrolled June 2017. Participants were accrued from a total of 11 sites across Brazil, South Africa, and the USA.
Pre-assignment Details Participants were stratified into the 3 Cohorts by age group and not randomized. There were no eligibility violations or errors to cohort assignments.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Period Title: Overall Study
Started 20 6 0 [1]
Completed [2] 4 2 0
Not Completed 16 4 0
Reason Not Completed
Withdrawal by Subject             1             1             0
On study due to Long-term Follow-up             15             3             0
[1]
No enrollments occurred into Cohort 3 during the study.
[2]
Study is ongoing, 5 year safety follow-up. Flow will be updated after completion of that period.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age Total
Hide Arm/Group Description

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Total of all reporting groups
Overall Number of Baseline Participants 11 4 0 15
Hide Baseline Analysis Population Description
Analysis population is defined as having been treated exclusively on the dose determined to be optimal for a given cohort and having either completed 48 weeks of exposure to the study drug or having been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 4 participants 0 participants 15 participants
4
(3 to 5)
1
(1 to 1)
3.5
(1 to 5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
Female
6
  54.5%
1
  25.0%
7
  46.7%
Male
5
  45.5%
3
  75.0%
8
  53.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
Hispanic or Latino
4
  36.4%
1
  25.0%
5
  33.3%
Not Hispanic or Latino
3
  27.3%
1
  25.0%
4
  26.7%
Unknown or Not Reported
4
  36.4%
2
  50.0%
6
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  72.7%
4
 100.0%
12
  80.0%
White
1
   9.1%
0
   0.0%
1
   6.7%
More than one race
1
   9.1%
0
   0.0%
1
   6.7%
Unknown or Not Reported
1
   9.1%
0
   0.0%
1
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
United States 2 1 3
Brazil 3 1 4
South Africa 6 2 8
Plasma HIV RNA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
<400 copies/ml
0
   0.0%
0
   0.0%
0
   0.0%
400 - <5,000 copies/ml
4
  36.4%
1
  25.0%
5
  33.3%
5,000 - <10,000 copies/ml
0
   0.0%
0
   0.0%
0
   0.0%
10,000 - < 25,000 copies/ml
2
  18.2%
1
  25.0%
3
  20.0%
25,000 - < 50,000 copies/ml
1
   9.1%
1
  25.0%
2
  13.3%
>=50,000 copies/ml
4
  36.4%
1
  25.0%
5
  33.3%
CD4 Count  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
50 - <200 cells/mm^3
1
   9.1%
0
   0.0%
1
   6.7%
200 - <350 cells/mm^3
1
   9.1%
0
   0.0%
1
   6.7%
350 - <500 cells/mm^3
1
   9.1%
1
  25.0%
2
  13.3%
>=500 cells/mm^3
8
  72.7%
3
  75.0%
11
  73.3%
CD4 Percent  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 0 participants 15 participants
<= 14 %
1
   9.1%
1
  25.0%
2
  13.3%
>14 - <25 %
5
  45.5%
1
  25.0%
6
  40.0%
>= 25 %
5
  45.5%
2
  50.0%
7
  46.7%
1.Primary Outcome
Title Termination From Treatment Due to a Suspected Adverse Drug Reaction (SADR)
Hide Description Number (%) of participants who discontinued treatment due to a suspected adverse drug reaction (SADR) by Cohort.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued treatment due to a SADR
1
   9.1%
0
   0.0%
Did not discontinue treatment due to a SADR
10
  90.9%
4
 100.0%
2.Primary Outcome
Title Adverse Events (AEs) of Grade 3 or Higher Severity
Hide Description Number (%) of participants who experienced a Grade 3 or higher severity adverse event through Week 48 by Cohort, with Clopper-Pearson confidence intervals.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Experienced a grade 3+ AE
4
  36.4%
4
 100.0%
Did not experience a grade 3+ AE
7
  63.6%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 36.4
Confidence Interval (2-Sided) 95%
10.9 to 69.2
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 100
Confidence Interval (2-Sided) 95%
39.8 to 100
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.
3.Primary Outcome
Title Death
Hide Description Number (%) of deaths on study by Cohort.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Deaths
0
   0.0%
0
   0.0%
Live participants
11
 100.0%
4
 100.0%
4.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve Over 12 Hours of ETR
Hide Description Geometric Mean (Standard Deviation) of the area under the plasma concentration-time curve over 12 hours (AUC12h) of ETR.
Time Frame Pre-dose, 1, 2, 4, 6, 9, and 12 hours post-dose measured at intensive PK visit (within 7-10 days after last dose of study drug administration)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure. They must also be considered PK evaluable by the study team; 1 Participant in Cohort 1 is not.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 10 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5512.85  (3615.36) 4821.76  (3167.11)
5.Secondary Outcome
Title AEs of Grade 3 or Higher Severity Judged to be at Least Possibly Attributable to the Study Medications
Hide Description Number (%) of Participants with AEs of Grade 3 or higher severity judged, by the Study Team, to be at least possibly attributable to the study medications by Cohort, including Clopper-Pearson confidence intervals.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Had a grade 3+ AE related to study drug
2
  18.2%
0
   0.0%
Had no grade 3+ AE related to study drug
9
  81.8%
4
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
2.5 to 51.8
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 60.2
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.
6.Secondary Outcome
Title HIV-1 RNA Virologic Failure Status at Weeks 24 and 48
Hide Description Number (%) of participants with confirmed Virologic Failure, defined as: failure to suppress plasma HIV-1 RNA to fewer than 400 copies/ml and failure to achieve at least a 2-log10 reduction (from baseline) in HIV-1 RNA at Weeks 24 or 48, by Cohort, with Clopper-Pearson confidence intervals. The initial HIV-1 RNA results that met the Virologic Failure definition were each confirmed by a second result obtained within 1 to 4 weeks of the initial result obtained at Week 24 and/or 48.
Time Frame Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Virologic Failure
2
  18.2%
1
  25.0%
No Virologic Failure
9
  81.8%
3
  75.0%
Week 48 Virologic Failure
3
  27.3%
3
  75.0%
No Virologic Failure
8
  72.7%
1
  25.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments Week 24 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
2.3 to 51.8
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments Week 24 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 25
Confidence Interval (2-Sided) 95%
0.6 to 80.6
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments Week 48 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 27.3
Confidence Interval (2-Sided) 95%
6 to 61
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments Week 48 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 75
Confidence Interval (2-Sided) 95%
19.4 to 99.4
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.
7.Secondary Outcome
Title Treatment Discontinued Due to Toxicity or Virologic Failure
Hide Description Number (%) of participants who discontinued study treatment (ETR) due to a toxicity or Virologic Failure (VF), by Cohort.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued Treatment due to VF
1
   9.1%
0
   0.0%
Did not discontinue treatment due to VF
10
  90.9%
4
 100.0%
8.Secondary Outcome
Title Change in Optimized Background Regimen Due to Virologic Failure
Hide Description Number (%) of participants who initiated a change in their optimized background regimen (OBR) due to virologic failure, by Cohort.
Time Frame Measured at entry and at Weeks 8, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Changed OBR due to Virologic Failure
0
   0.0%
0
   0.0%
Did not change OBR due to Virologic Failure
11
 100.0%
4
 100.0%
9.Secondary Outcome
Title New Onset Opportunistic Infection (OI) or AIDS Diagnosis
Hide Description Number (%) of participants with a new onset opportunistic infection (OI) or AIDS diagnosis, by Cohort.
Time Frame From baseline to occurrence of event, up to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Had a new OI
0
   0.0%
0
   0.0%
Had no new OIs
11
 100.0%
4
 100.0%
10.Secondary Outcome
Title Decline in Absolute CD4 Percent of Greater Than 5 Percent Any Time After 12 Weeks of Therapy
Hide Description Number (%) of participants with a >5% decline in absolute CD4 percent from baseline at weeks 12, 24, and 48, by Cohort, including Clopper-Pearson confidence intervals.
Time Frame Measured at baseline and at Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age Cohort III: Treatment Experienced, 2 Months to 1 Year of Age
Hide Arm/Group Description:

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Overall Number of Participants Analyzed 11 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 >5% decline in CD4 % from baseline
1
   9.1%
2
  50.0%
Increase or <5% decline in CD4 % from baseline
10
  90.9%
2
  50.0%
Week 24 >5% decline in CD4 % from baseline
1
   9.1%
1
  25.0%
Increase or <5% decline in CD4 % from baseline
10
  90.9%
3
  75.0%
Week 48 >5% decline in CD4 % from baseline
2
  18.2%
2
  50.0%
Increase or <5% decline in CD4 % from baseline
9
  81.8%
2
  50.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments Week 12 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
0.2 to 41.3
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a >5% decline in absolute CD4 %.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments Week 12 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 50
Confidence Interval (2-Sided) 95%
6.8 to 93.2
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a >5% decline in absolute CD4 %.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments Week 24 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
0.2 to 41.3
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a >5% decline in absolute CD4 %.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments Week 24 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 25
Confidence Interval (2-Sided) 95%
0.6 to 80.6
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a >5% decline in absolute CD4 %.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort I: Treatment Experienced, 2 to 6 Years of Age
Comments Week 48 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
2.3 to 51.8
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a >5% decline in absolute CD4 %.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort II: Treatment Experienced, 1 to 2 Years of Age
Comments Week 48 time point.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter %
Estimated Value 50
Confidence Interval (2-Sided) 95%
6.8 to 93.2
Estimation Comments Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a >5% decline in absolute CD4 %.
Time Frame From entry until Primary Completion Date (July 17, 2018) or premature study discontinuation, with evaluations at Week 0, 2, 4, 8, 12, 16, 24, 32, 40, 48, and every 12 weeks after that, an average of 72 weeks. AEs reported will be updated after study completion to include the 5-year follow-up.
Adverse Event Reporting Description At entry, all diagnoses, signs/symptoms and laboratory events were collected. Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥Grade 1 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
 
Arm/Group Title Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age
Hide Arm/Group Description

Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.

Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.

All-Cause Mortality
Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   4/6 (66.67%) 
Blood and lymphatic system disorders     
Anaemia  1  0/20 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications     
Ligament sprain  1  0/20 (0.00%)  1/6 (16.67%) 
Investigations     
Lipase increased  1  2/20 (10.00%)  0/6 (0.00%) 
Neutrophil count decreased  1  1/20 (5.00%)  1/6 (16.67%) 
Platelet count decreased  1  1/20 (5.00%)  1/6 (16.67%) 
Transaminases increased  1  0/20 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort I: Treatment Experienced, 2 to 6 Years of Age Cohort II: Treatment Experienced, 1 to 2 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  2/20 (10.00%)  2/6 (33.33%) 
Lymphadenopathy  1  7/20 (35.00%)  3/6 (50.00%) 
Splenomegaly  1  0/20 (0.00%)  1/6 (16.67%) 
Cardiac disorders     
Tachycardia  1  0/20 (0.00%)  1/6 (16.67%) 
Congenital, familial and genetic disorders     
Keratosis follicular  1  1/20 (5.00%)  0/6 (0.00%) 
Ear and labyrinth disorders     
Ear pain  1  2/20 (10.00%)  1/6 (16.67%) 
External ear inflammation  1  1/20 (5.00%)  0/6 (0.00%) 
Otorrhoea  1  2/20 (10.00%)  3/6 (50.00%) 
Eye disorders     
Eye discharge  1  2/20 (10.00%)  0/6 (0.00%) 
Eye pruritus  1  1/20 (5.00%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/20 (0.00%)  1/6 (16.67%) 
Abdominal pain  1  3/20 (15.00%)  0/6 (0.00%) 
Abdominal pain upper  1  1/20 (5.00%)  0/6 (0.00%) 
Anal pruritus  1  2/20 (10.00%)  0/6 (0.00%) 
Constipation  1  2/20 (10.00%)  0/6 (0.00%) 
Diarrhoea  1  5/20 (25.00%)  4/6 (66.67%) 
Frequent bowel movements  1  1/20 (5.00%)  0/6 (0.00%) 
Lip ulceration  1  0/20 (0.00%)  1/6 (16.67%) 
Mouth ulceration  1  2/20 (10.00%)  1/6 (16.67%) 
Nausea  1  0/20 (0.00%)  1/6 (16.67%) 
Oral disorder  1  2/20 (10.00%)  1/6 (16.67%) 
Oral mucosal eruption  1  1/20 (5.00%)  0/6 (0.00%) 
Palatal disorder  1  0/20 (0.00%)  1/6 (16.67%) 
Parotid gland enlargement  1  1/20 (5.00%)  0/6 (0.00%) 
Toothache  1  1/20 (5.00%)  0/6 (0.00%) 
Vomiting  1  3/20 (15.00%)  1/6 (16.67%) 
General disorders     
Chills  1  1/20 (5.00%)  0/6 (0.00%) 
Fatigue  1  1/20 (5.00%)  0/6 (0.00%) 
Mucosal discolouration  1  0/20 (0.00%)  1/6 (16.67%) 
Pyrexia  1  10/20 (50.00%)  3/6 (50.00%) 
Hepatobiliary disorders     
Hepatomegaly  1  0/20 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Abscess limb  1  0/20 (0.00%)  1/6 (16.67%) 
Acarodermatitis  1  2/20 (10.00%)  0/6 (0.00%) 
Acute sinusitis  1  2/20 (10.00%)  0/6 (0.00%) 
Adenoiditis  1  0/20 (0.00%)  1/6 (16.67%) 
Body tinea  1  1/20 (5.00%)  0/6 (0.00%) 
Bronchitis  1  2/20 (10.00%)  0/6 (0.00%) 
Enterobiasis  1  1/20 (5.00%)  0/6 (0.00%) 
Epstein-Barr virus infection  1  1/20 (5.00%)  0/6 (0.00%) 
Gastroenteritis  1  1/20 (5.00%)  1/6 (16.67%) 
Helminthic infection  1  1/20 (5.00%)  0/6 (0.00%) 
Herpes simplex  1  1/20 (5.00%)  0/6 (0.00%) 
Herpes zoster  1  1/20 (5.00%)  0/6 (0.00%) 
Impetigo  1  4/20 (20.00%)  1/6 (16.67%) 
Latent tuberculosis  1  1/20 (5.00%)  0/6 (0.00%) 
Lice infestation  1  3/20 (15.00%)  0/6 (0.00%) 
Molluscum contagiosum  1  2/20 (10.00%)  0/6 (0.00%) 
Nasopharyngitis  1  1/20 (5.00%)  1/6 (16.67%) 
Oral candidiasis  1  1/20 (5.00%)  1/6 (16.67%) 
Oral herpes  1  1/20 (5.00%)  0/6 (0.00%) 
Otitis media  1  0/20 (0.00%)  1/6 (16.67%) 
Otitis media acute  1  2/20 (10.00%)  3/6 (50.00%) 
Parasitic gastroenteritis  1  1/20 (5.00%)  0/6 (0.00%) 
Parotitis  1  1/20 (5.00%)  1/6 (16.67%) 
Pharyngitis  1  7/20 (35.00%)  1/6 (16.67%) 
Pneumonia bacterial  1  2/20 (10.00%)  0/6 (0.00%) 
Purulent discharge  1  1/20 (5.00%)  0/6 (0.00%) 
Rash pustular  1  1/20 (5.00%)  0/6 (0.00%) 
Rhinitis  1  1/20 (5.00%)  0/6 (0.00%) 
Skin infection  1  1/20 (5.00%)  0/6 (0.00%) 
Tinea capitis  1  6/20 (30.00%)  0/6 (0.00%) 
Tinea faciei  1  2/20 (10.00%)  0/6 (0.00%) 
Tinea manuum  1  1/20 (5.00%)  0/6 (0.00%) 
Tonsillitis  1  2/20 (10.00%)  2/6 (33.33%) 
Toxocariasis  1  1/20 (5.00%)  0/6 (0.00%) 
Upper respiratory tract infection  1  2/20 (10.00%)  1/6 (16.67%) 
Urinary tract infection  1  2/20 (10.00%)  0/6 (0.00%) 
Varicella  1  1/20 (5.00%)  0/6 (0.00%) 
Viral infection  1  1/20 (5.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  2/20 (10.00%)  0/6 (0.00%) 
Mucosal excoriation  1  1/20 (5.00%)  0/6 (0.00%) 
Thermal burn  1  1/20 (5.00%)  0/6 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  5/20 (25.00%)  3/6 (50.00%) 
Aspartate aminotransferase increased  1  4/20 (20.00%)  2/6 (33.33%) 
Blood alkaline phosphatase increased  1  6/20 (30.00%)  1/6 (16.67%) 
Blood bicarbonate decreased  1  17/20 (85.00%)  5/6 (83.33%) 
Blood bilirubin increased  1  3/20 (15.00%)  0/6 (0.00%) 
Blood calcium increased  1  1/20 (5.00%)  1/6 (16.67%) 
Blood cholesterol increased  1  3/20 (15.00%)  1/6 (16.67%) 
Blood creatinine increased  1  1/20 (5.00%)  1/6 (16.67%) 
Blood glucose decreased  1  6/20 (30.00%)  0/6 (0.00%) 
Blood glucose increased  1  12/20 (60.00%)  2/6 (33.33%) 
Blood pH decreased  1  1/20 (5.00%)  1/6 (16.67%) 
Blood pH increased  1  1/20 (5.00%)  0/6 (0.00%) 
Blood phosphorus decreased  1  1/20 (5.00%)  0/6 (0.00%) 
Blood potassium decreased  1  1/20 (5.00%)  0/6 (0.00%) 
Blood potassium increased  1  2/20 (10.00%)  3/6 (50.00%) 
Blood pressure diastolic increased  1  4/20 (20.00%)  3/6 (50.00%) 
Blood pressure systolic  1  0/20 (0.00%)  1/6 (16.67%) 
Blood pressure systolic increased  1  1/20 (5.00%)  3/6 (50.00%) 
Blood sodium decreased  1  14/20 (70.00%)  4/6 (66.67%) 
Blood sodium increased  1  0/20 (0.00%)  1/6 (16.67%) 
Breath sounds abnormal  1  0/20 (0.00%)  1/6 (16.67%) 
Haemoglobin decreased  1  6/20 (30.00%)  5/6 (83.33%) 
International normalised ratio increased  1  1/20 (5.00%)  0/6 (0.00%) 
Lipase increased  1  1/20 (5.00%)  0/6 (0.00%) 
Low density lipoprotein increased  1  1/20 (5.00%)  0/6 (0.00%) 
Neutrophil count decreased  1  9/20 (45.00%)  3/6 (50.00%) 
Platelet count decreased  1  1/20 (5.00%)  2/6 (33.33%) 
Prothrombin time prolonged  1  1/20 (5.00%)  0/6 (0.00%) 
Weight decreased  1  1/20 (5.00%)  2/6 (33.33%) 
Weight increased  1  1/20 (5.00%)  0/6 (0.00%) 
White blood cell count decreased  1  1/20 (5.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  4/20 (20.00%)  2/6 (33.33%) 
Failure to thrive  1  2/20 (10.00%)  2/6 (33.33%) 
Vitamin D deficiency  1  1/20 (5.00%)  0/6 (0.00%) 
Weight gain poor  1  0/20 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/20 (5.00%)  0/6 (0.00%) 
Clubbing  1  1/20 (5.00%)  0/6 (0.00%) 
Myalgia  1  1/20 (5.00%)  0/6 (0.00%) 
Neck pain  1  1/20 (5.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  1/20 (5.00%)  0/6 (0.00%) 
Nervous system disorders     
Dizziness  1  1/20 (5.00%)  0/6 (0.00%) 
Headache  1  3/20 (15.00%)  0/6 (0.00%) 
Hypotonia  1  0/20 (0.00%)  1/6 (16.67%) 
Lethargy  1  2/20 (10.00%)  0/6 (0.00%) 
Motor developmental delay  1  0/20 (0.00%)  1/6 (16.67%) 
Speech disorder developmental  1  0/20 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
Insomnia  1  1/20 (5.00%)  0/6 (0.00%) 
Irritability  1  1/20 (5.00%)  0/6 (0.00%) 
Reproductive system and breast disorders     
Genital rash  1  1/20 (5.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adenoidal hypertrophy  1  1/20 (5.00%)  0/6 (0.00%) 
Asthma  1  1/20 (5.00%)  1/6 (16.67%) 
Bronchiectasis  1  1/20 (5.00%)  0/6 (0.00%) 
Bronchospasm  1  2/20 (10.00%)  1/6 (16.67%) 
Cough  1  13/20 (65.00%)  6/6 (100.00%) 
Dyspnoea  1  1/20 (5.00%)  1/6 (16.67%) 
Nasal congestion  1  14/20 (70.00%)  6/6 (100.00%) 
Nasal pruritus  1  1/20 (5.00%)  0/6 (0.00%) 
Oropharyngeal pain  1  3/20 (15.00%)  0/6 (0.00%) 
Pharyngeal erythema  1  2/20 (10.00%)  0/6 (0.00%) 
Pharyngeal inflammation  1  2/20 (10.00%)  1/6 (16.67%) 
Rales  1  3/20 (15.00%)  1/6 (16.67%) 
Rhinitis allergic  1  1/20 (5.00%)  0/6 (0.00%) 
Rhinorrhoea  1  9/20 (45.00%)  5/6 (83.33%) 
Rhonchi  1  0/20 (0.00%)  1/6 (16.67%) 
Sinus congestion  1  1/20 (5.00%)  0/6 (0.00%) 
Sleep apnoea syndrome  1  1/20 (5.00%)  0/6 (0.00%) 
Sneezing  1  2/20 (10.00%)  0/6 (0.00%) 
Snoring  1  1/20 (5.00%)  0/6 (0.00%) 
Tonsillar hypertrophy  1  1/20 (5.00%)  0/6 (0.00%) 
Tonsillar inflammation  1  1/20 (5.00%)  0/6 (0.00%) 
Upper-airway cough syndrome  1  1/20 (5.00%)  0/6 (0.00%) 
Wheezing  1  1/20 (5.00%)  2/6 (33.33%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  1/20 (5.00%)  1/6 (16.67%) 
Dermatitis atopic  1  1/20 (5.00%)  0/6 (0.00%) 
Dermatitis contact  1  1/20 (5.00%)  0/6 (0.00%) 
Dry skin  1  4/20 (20.00%)  0/6 (0.00%) 
Eczema  1  3/20 (15.00%)  1/6 (16.67%) 
Erythema  1  1/20 (5.00%)  0/6 (0.00%) 
Hand dermatitis  1  1/20 (5.00%)  0/6 (0.00%) 
Macule  1  1/20 (5.00%)  0/6 (0.00%) 
Neurodermatitis  1  1/20 (5.00%)  0/6 (0.00%) 
Night sweats  1  1/20 (5.00%)  0/6 (0.00%) 
Papule  1  3/20 (15.00%)  1/6 (16.67%) 
Rash  1  9/20 (45.00%)  2/6 (33.33%) 
Rash erythematous  1  1/20 (5.00%)  0/6 (0.00%) 
Rash generalised  1  3/20 (15.00%)  1/6 (16.67%) 
Rash papular  1  2/20 (10.00%)  0/6 (0.00%) 
Rash pruritic  1  2/20 (10.00%)  0/6 (0.00%) 
Scab  1  1/20 (5.00%)  0/6 (0.00%) 
Skin induration  1  0/20 (0.00%)  1/6 (16.67%) 
Urticaria  1  1/20 (5.00%)  0/6 (0.00%) 
Xeroderma  1  1/20 (5.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Due to the slow rate of accrual and the challenging accrual into the youngest cohort, enrollment was stopped early.
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
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01504841    
Other Study ID Numbers: P1090
10850 ( Other Identifier: DAIDS-ES )
First Submitted: December 30, 2011
First Posted: January 5, 2012
Results First Submitted: July 16, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019