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Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

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ClinicalTrials.gov Identifier: NCT01923311
Recruitment Status : Terminated
First Posted : August 15, 2013
Results First Posted : July 11, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Interventions Drug: EVG
Drug: Background regimen
Enrollment 31

Recruitment Details Participants were enrolled at study sites in North America, Europe, Asia, and Africa. The first participant was screened on 26 August 2013. The last study visit occurred on 03 November 2017.
Pre-assignment Details

48 participants were screened.

The study was discontinued after enrollment of only Cohort 1, Part B and Cohort 2, Part A. The study close-out was triggered by the voluntary withdrawal of single-agent Vitekta® sale based solely on low utilization of the product, and was not a result of any ongoing or new safety issue.

Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.).
Period Title: Overall Study
Started 17 14
Completed 0 13
Not Completed 17 1
Reason Not Completed
Pregnancy             1             0
Investigator's Discretion             1             0
Non-Compliance with Study Drug             2             1
Withdrew Consent             1             0
Study Terminated by Sponsor             12             0
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL Total
Hide Arm/Group Description EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks with the option to continue receiving EVG after Week 48 in the extension phase, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.) Total of all reporting groups
Overall Number of Baseline Participants 17 14 31
Hide Baseline Analysis Population Description
Safety Analysis Set: all participants who were enrolled into the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 31 participants
14  (2.9) 9  (2.2) 12  (3.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Age 6 to < 12 Years
2
  11.8%
14
 100.0%
16
  51.6%
Age 12 to < 18 Years
15
  88.2%
0
   0.0%
15
  48.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Female
11
  64.7%
6
  42.9%
17
  54.8%
Male
6
  35.3%
8
  57.1%
14
  45.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Asian
5
  29.4%
2
  14.3%
7
  22.6%
Black
11
  64.7%
10
  71.4%
21
  67.7%
White
0
   0.0%
2
  14.3%
2
   6.5%
Other
1
   5.9%
0
   0.0%
1
   3.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Hispanic or Latino
0
   0.0%
1
   7.1%
1
   3.2%
Not Hispanic or Latino
17
 100.0%
13
  92.9%
30
  96.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
United States
1
   5.9%
7
  50.0%
8
  25.8%
Italy
1
   5.9%
0
   0.0%
1
   3.2%
South Africa
7
  41.2%
0
   0.0%
7
  22.6%
Uganda
3
  17.6%
3
  21.4%
6
  19.4%
Thailand
5
  29.4%
2
  14.3%
7
  22.6%
Spain
0
   0.0%
2
  14.3%
2
   6.5%
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 17 participants 14 participants 31 participants
4.21  (0.802) 1.33  (0.204) 2.91  (1.576)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
< 50 copies/mL
0
   0.0%
13
  92.9%
13
  41.9%
≥ 50 to ≤ 1000 copies/mL
3
  17.6%
1
   7.1%
4
  12.9%
> 1000 to ≤ 100000 copies/mL
13
  76.5%
0
   0.0%
13
  41.9%
> 100000 copies/mL
1
   5.9%
0
   0.0%
1
   3.2%
Cluster of differentiation (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 17 participants 14 participants 31 participants
356.6  (249.45) 810.8  (303.29) 561.7  (354.74)
Cluster of differentiation (CD4) Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
< 50 cells/uL
0
   0.0%
0
   0.0%
0
   0.0%
≥ 50 to < 200 cells/uL
6
  35.3%
1
   7.1%
7
  22.6%
≥ 200 to < 350 cells/uL
3
  17.6%
0
   0.0%
3
   9.7%
≥ 350 to < 500 cells/uL
4
  23.5%
0
   0.0%
4
  12.9%
≥ 500 cells/uL
4
  23.5%
13
  92.9%
17
  54.8%
Cluster of differentiation (CD4) Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage (%)
Number Analyzed 17 participants 14 participants 31 participants
17.8  (9.60) 35.5  (9.11) 25.8  (12.85)
Type of PI in Background Regimen (Excluding Ritonavir)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
atazanavir
8
  47.1%
1
   7.1%
9
  29.0%
darunavir
3
  17.6%
0
   0.0%
3
   9.7%
lopinavir
6
  35.3%
13
  92.9%
19
  61.3%
1.Primary Outcome
Title Pharmacokinetic (PK) Parameter: AUCtau of EVG
Hide Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame Predose and up to 12 hours postdose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Set(EVG): all enrolled participants who received at least 1 dose of study drug and for whom steady-state pharmacokinetic profiles of the analyte of interest at the Intensive PK(Day 10) visit were evaluable.Includes 12 participants with screening HIV-1 RNA<50 copies/mL and 2 participants with screening HIV-1 RNA>1000 copies/mL.
Arm/Group Title Age 6 to < 12 Years
Hide Arm/Group Description:

PK results were summarized for all participants age 6 to < 12 years as one group.

EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
24028.3  (7302.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Age 6 to < 12 Years
Comments To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).
Type of Statistical Test Equivalence
Comments A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).
Method of Estimation Estimation Parameter GLSM Ratio (%) (Test/Reference)
Estimated Value 135.73
Confidence Interval (2-Sided) 90%
116.24 to 158.49
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10
Hide Description Cmax is defined as the maximum concentration of drug.
Time Frame Predose and up to 12 hours postdose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Set (EVG)
Arm/Group Title Age 6 to < 12 Years
Hide Arm/Group Description:

PK results were summarized for all participants age 6 to < 12 years as one group.

EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
2022.1  (599.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Age 6 to < 12 Years
Comments To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).
Type of Statistical Test Equivalence
Comments A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).
Method of Estimation Estimation Parameter GLSM Ratio (%) (Test/Reference)
Estimated Value 146.68
Confidence Interval (2-Sided) 90%
127.35 to 168.94
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Experiencing Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: percentage of participants
100.0 35.7
4.Primary Outcome
Title Percentage of Participants Experiencing Laboratory Abnormalities
Hide Description Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).
Time Frame Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 11.8 50.0
Grade 2 35.3 21.4
Grade 3 35.3 7.1
Grade 4 17.6 0
5.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Ctau of EVG
Hide Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time Frame Predose and up to 12 hours postdose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis Set (EVG)
Arm/Group Title Age 6 to < 12 Years
Hide Arm/Group Description:

PK results were summarized for all participants age 6 to < 12 years as one group.

EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
494.3  (261.05)
6.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: CL/F of EVG
Hide Description CL/F is defined as the apparent oral clearance following administration of the drug.
Time Frame Predose and up to 12 hours postdose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intensive PK Analysis set (EVG)
Arm/Group Title Age 6 to < 12 Years
Hide Arm/Group Description:

PK results were summarized for all participants age 6 to < 12 years as one group.

EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mL/h
2863.5  (871.07)
7.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Vz/F of EVG
Hide Description Vz/F is defined as the apparent volume of distribution of the drug.
Time Frame Predose and up to 12 hours postdose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intensive PK Analysis Set: EVG with available data were analyzed.
Arm/Group Title Age 6 to < 12 Years
Hide Arm/Group Description:

PK results were summarized for all participants age 6 to < 12 years as one group.

EVG 50 mg, or 85 mg tablet administered QD for 10 days (participants with screening HIV-1 RNA < 50 copies/mL), or at least 48 weeks (participants with screening HIV-1 RNA > 1000 copies/mL), based on body weight and dependent on the coadministered background regimen (For participants receiving ATV/r or LPV/r, the EVG dose was 50 mg for participants ≥ 17 to < 30 kg and 85 mg for participants ≥ 30 kg).

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mL
39508.3  (14071.51)
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.5
(50.1 to 93.2)
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.8
(32.9 to 81.6)
10.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.4
(56.6 to 96.2)
11.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
Hide Description The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.5
(50.1 to 93.2)
12.Secondary Outcome
Title Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 24 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 16 0
Mean (Standard Deviation)
Unit of Measure: Log₁₀ copies/mL
-2.44  (1.132)
13.Secondary Outcome
Title Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 48 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 15 0
Mean (Standard Deviation)
Unit of Measure: Log₁₀ copies/ mL
-2.23  (1.293)
14.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 16 0
Mean (Standard Deviation)
Unit of Measure: cells/uL
77.6  (138.06)
15.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 15 0
Mean (Standard Deviation)
Unit of Measure: cells/uL
131.3  (195.04)
16.Secondary Outcome
Title Change From Baseline in CD4 Percentage at Week 24
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 16 0
Mean (Standard Deviation)
Unit of Measure: percentage (%)
3.56  (4.109)
17.Secondary Outcome
Title Change From Baseline in CD4 Percentage at Week 48
Hide Description [Not Specified]
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 15 0
Mean (Standard Deviation)
Unit of Measure: percentage (%)
5.31  (5.772)
18.Secondary Outcome
Title Tanner Stage Evaluation by Sex at Week 24
Hide Description Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Female: Pubic Hair Number Analyzed 11 participants 0 participants
Stage 1
1
   9.1%
Stage 2
0
   0.0%
Stage 3
4
  36.4%
Stage 4
5
  45.5%
Stage 5
1
   9.1%
Missing
0
   0.0%
Female: Breasts Number Analyzed 11 participants 0 participants
Stage 1
0
   0.0%
Stage 2
0
   0.0%
Stage 3
3
  27.3%
Stage 4
5
  45.5%
Stage 5
3
  27.3%
Missing
0
   0.0%
Male: Pubic Hair Number Analyzed 6 participants 0 participants
Stage 1
2
  33.3%
Stage 2
2
  33.3%
Stage 3
0
   0.0%
Stage 4
0
   0.0%
Stage 5
2
  33.3%
Missing
0
   0.0%
Male: Genitalia Number Analyzed 6 participants 0 participants
Stage 1
2
  33.3%
Stage 2
2
  33.3%
Stage 3
0
   0.0%
Stage 4
0
   0.0%
Stage 5
2
  33.3%
Missing
0
   0.0%
19.Secondary Outcome
Title Tanner Stage Evaluation by Sex at Week 48
Hide Description Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Female: Pubic Hair Number Analyzed 11 participants 0 participants
Stage 1
0
   0.0%
Stage 2
1
   9.1%
Stage 3
4
  36.4%
Stage 4
4
  36.4%
Stage 5
1
   9.1%
Missing
1
   9.1%
Female: Breasts Number Analyzed 11 participants 0 participants
Stage 1
0
   0.0%
Stage 2
0
   0.0%
Stage 3
2
  18.2%
Stage 4
5
  45.5%
Stage 5
3
  27.3%
Missing
1
   9.1%
Male: Pubic Hair Number Analyzed 6 participants 0 participants
Stage 1
3
  50.0%
Stage 2
1
  16.7%
Stage 3
0
   0.0%
Stage 4
1
  16.7%
Stage 5
1
  16.7%
Missing
0
   0.0%
Male: Genitalia Number Analyzed 6 participants 0 participants
Stage 1
2
  33.3%
Stage 2
2
  33.3%
Stage 3
0
   0.0%
Stage 4
0
   0.0%
Stage 5
2
  33.3%
Missing
0
   0.0%
20.Secondary Outcome
Title Age of First Menses
Hide Description Age of first menses for female participants.
Time Frame Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. Age of First Menses for participants ages 6 to < 12 years with screening HIV-1 RNA < 50 copies/mL was not analyzed because none of the participants reached their first menstruation cycle during or prior to the study.
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 11 0
Mean (Standard Deviation)
Unit of Measure: years
13  (1.9)
21.Secondary Outcome
Title Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group
Hide Description [Not Specified]
Time Frame Up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Palatability was only to be assessed for participants taking EVG suspension formulation. As no participants were dosed with the EVG oral suspension formulation, no data are available on its palatability.
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Adherence to EVG
Hide Description Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100.
Time Frame Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description:
EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: percentage of pills
91.1  (8.94) 100.0  (0.00)
Time Frame Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)
Adverse Event Reporting Description Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.
 
Arm/Group Title Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Hide Arm/Group Description EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG. EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
All-Cause Mortality
Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   2/17 (11.76%)   1/14 (7.14%) 
Infections and infestations     
Bronchitis  1  1/17 (5.88%)  0/14 (0.00%) 
Plasmodium falciparum infection  1  0/17 (0.00%)  1/14 (7.14%) 
Skin candida  1  1/17 (5.88%)  0/14 (0.00%) 
Syphilis  1  1/17 (5.88%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
Affected / at Risk (%) Affected / at Risk (%)
Total   17/17 (100.00%)   5/14 (35.71%) 
Blood and lymphatic system disorders     
Neutropenia  1  1/17 (5.88%)  0/14 (0.00%) 
Cardiac disorders     
Tachycardia  1  1/17 (5.88%)  0/14 (0.00%) 
Ear and labyrinth disorders     
Tympanic membrane perforation  1  1/17 (5.88%)  0/14 (0.00%) 
Eye disorders     
Eye pruritus  1  0/17 (0.00%)  1/14 (7.14%) 
Ocular hyperaemia  1  0/17 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders     
Abdominal pain  1  2/17 (11.76%)  0/14 (0.00%) 
Abdominal pain lower  1  1/17 (5.88%)  0/14 (0.00%) 
Aphthous ulcer  1  3/17 (17.65%)  0/14 (0.00%) 
Dental caries  1  2/17 (11.76%)  0/14 (0.00%) 
Diarrhoea  1  3/17 (17.65%)  0/14 (0.00%) 
Nausea  1  1/17 (5.88%)  0/14 (0.00%) 
Pancreatitis  1  1/17 (5.88%)  0/14 (0.00%) 
Vomiting  1  2/17 (11.76%)  0/14 (0.00%) 
General disorders     
Asthenia  1  1/17 (5.88%)  0/14 (0.00%) 
Chest pain  1  1/17 (5.88%)  0/14 (0.00%) 
Peripheral swelling  1  1/17 (5.88%)  0/14 (0.00%) 
Pyrexia  1  1/17 (5.88%)  0/14 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/17 (5.88%)  0/14 (0.00%) 
Jaundice  1  2/17 (11.76%)  0/14 (0.00%) 
Immune system disorders     
Allergy to arthropod bite  1  1/17 (5.88%)  0/14 (0.00%) 
Infections and infestations     
Body tinea  1  1/17 (5.88%)  0/14 (0.00%) 
Bronchitis  1  1/17 (5.88%)  0/14 (0.00%) 
Conjunctivitis  1  1/17 (5.88%)  0/14 (0.00%) 
Folliculitis  1  1/17 (5.88%)  0/14 (0.00%) 
Gastroenteritis  1  1/17 (5.88%)  0/14 (0.00%) 
Gingivitis  1  1/17 (5.88%)  0/14 (0.00%) 
Herpes simplex  1  1/17 (5.88%)  0/14 (0.00%) 
Herpes zoster  1  1/17 (5.88%)  0/14 (0.00%) 
Lower respiratory tract infection  1  1/17 (5.88%)  0/14 (0.00%) 
Oral candidiasis  1  1/17 (5.88%)  0/14 (0.00%) 
Otitis externa  1  1/17 (5.88%)  0/14 (0.00%) 
Otitis media  1  1/17 (5.88%)  0/14 (0.00%) 
Otitis media acute  1  2/17 (11.76%)  0/14 (0.00%) 
Parotid abscess  1  1/17 (5.88%)  0/14 (0.00%) 
Respiratory tract infection  1  1/17 (5.88%)  0/14 (0.00%) 
Rhinitis  1  1/17 (5.88%)  0/14 (0.00%) 
Sinusitis  1  1/17 (5.88%)  0/14 (0.00%) 
Skin bacterial infection  1  1/17 (5.88%)  0/14 (0.00%) 
Skin infection  1  1/17 (5.88%)  0/14 (0.00%) 
Tonsillitis  1  2/17 (11.76%)  0/14 (0.00%) 
Tooth abscess  1  1/17 (5.88%)  0/14 (0.00%) 
Upper respiratory tract infection  1  11/17 (64.71%)  0/14 (0.00%) 
Urinary tract infection  1  2/17 (11.76%)  0/14 (0.00%) 
Varicella  1  1/17 (5.88%)  0/14 (0.00%) 
Viral upper respiratory tract infection  1  1/17 (5.88%)  1/14 (7.14%) 
Vulvovaginal mycotic infection  1  2/17 (11.76%)  0/14 (0.00%) 
Injury, poisoning and procedural complications     
Animal bite  1  1/17 (5.88%)  0/14 (0.00%) 
Muscle injury  1  1/17 (5.88%)  0/14 (0.00%) 
Soft tissue injury  1  1/17 (5.88%)  0/14 (0.00%) 
Thermal burn  1  1/17 (5.88%)  0/14 (0.00%) 
Investigations     
Blood bilirubin increased  1  3/17 (17.65%)  0/14 (0.00%) 
Blood creatine phosphokinase increased  1  1/17 (5.88%)  0/14 (0.00%) 
Crystal urine present  1  1/17 (5.88%)  0/14 (0.00%) 
Lymph node palpable  1  1/17 (5.88%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Hyperamylasaemia  1  1/17 (5.88%)  0/14 (0.00%) 
Hyperlipasaemia  1  1/17 (5.88%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/17 (5.88%)  0/14 (0.00%) 
Myalgia  1  1/17 (5.88%)  0/14 (0.00%) 
Nervous system disorders     
Dizziness  1  1/17 (5.88%)  1/14 (7.14%) 
Headache  1  3/17 (17.65%)  0/14 (0.00%) 
Parosmia  1  1/17 (5.88%)  0/14 (0.00%) 
Renal and urinary disorders     
Dysuria  1  0/17 (0.00%)  1/14 (7.14%) 
Haematuria  1  0/17 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/17 (5.88%)  0/14 (0.00%) 
Genital ulceration  1  1/17 (5.88%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/17 (5.88%)  0/14 (0.00%) 
Cough  1  3/17 (17.65%)  0/14 (0.00%) 
Epistaxis  1  0/17 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders     
Eczema  1  2/17 (11.76%)  0/14 (0.00%) 
Rash  1  1/17 (5.88%)  0/14 (0.00%) 
Rash maculo-papular  1  1/17 (5.88%)  0/14 (0.00%) 
Rash papular  1  1/17 (5.88%)  0/14 (0.00%) 
Vitiligo  1  1/17 (5.88%)  0/14 (0.00%) 
Vascular disorders     
Pallor  1  1/17 (5.88%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01923311     History of Changes
Other Study ID Numbers: GS-US-183-0160
2013-001969-16 ( EudraCT Number )
First Submitted: August 9, 2013
First Posted: August 15, 2013
Results First Submitted: April 24, 2018
Results First Posted: July 11, 2018
Last Update Posted: August 9, 2018