Trial Outcomes & Findings for 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 (NCT NCT01923311)

NCT ID: NCT01923311

Last Updated: 2018-08-09

Results Overview

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

31 participants

Primary outcome timeframe

Predose and up to 12 hours postdose on Day 10

Results posted on

2018-08-09

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL 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.	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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 Study STARTED	17	14
Overall Study COMPLETED	0	13
Overall Study NOT COMPLETED	17	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL 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.	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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 Study Pregnancy	1	0
Overall Study Investigator's Discretion	1	0
Overall Study Non-Compliance with Study Drug	2	1
Overall Study Withdrew Consent	1	0
Overall Study Study Terminated by Sponsor	12	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL n=17 Participants 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.	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL n=14 Participants 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 n=31 Participants Total of all reporting groups
Age, Continuous	14 years STANDARD_DEVIATION 2.9 • n=5 Participants	9 years STANDARD_DEVIATION 2.2 • n=7 Participants	12 years STANDARD_DEVIATION 3.8 • n=5 Participants
Age, Customized Age 6 to < 12 Years	2 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized Age 12 to < 18 Years	15 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Italy	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment South Africa	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Uganda	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Thailand	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
HIV-1 RNA	4.21 log10 copies/mL STANDARD_DEVIATION 0.802 • n=5 Participants	1.33 log10 copies/mL STANDARD_DEVIATION 0.204 • n=7 Participants	2.91 log10 copies/mL STANDARD_DEVIATION 1.576 • n=5 Participants
HIV-1 RNA Category < 50 copies/mL	0 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 to ≤ 1000 copies/mL	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
HIV-1 RNA Category > 1000 to ≤ 100000 copies/mL	13 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants
HIV-1 RNA Category > 100000 copies/mL	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cluster of differentiation (CD4) Cell Count	356.6 cells/uL STANDARD_DEVIATION 249.45 • n=5 Participants	810.8 cells/uL STANDARD_DEVIATION 303.29 • n=7 Participants	561.7 cells/uL STANDARD_DEVIATION 354.74 • n=5 Participants
Cluster of differentiation (CD4) Cell Count Category < 50 cells/uL	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cluster of differentiation (CD4) Cell Count Category ≥ 50 to < 200 cells/uL	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Cluster of differentiation (CD4) Cell Count Category ≥ 200 to < 350 cells/uL	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Cluster of differentiation (CD4) Cell Count Category ≥ 350 to < 500 cells/uL	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Cluster of differentiation (CD4) Cell Count Category ≥ 500 cells/uL	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Cluster of differentiation (CD4) Percentage	17.8 percentage (%) STANDARD_DEVIATION 9.60 • n=5 Participants	35.5 percentage (%) STANDARD_DEVIATION 9.11 • n=7 Participants	25.8 percentage (%) STANDARD_DEVIATION 12.85 • n=5 Participants
Type of PI in Background Regimen (Excluding Ritonavir) atazanavir	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Type of PI in Background Regimen (Excluding Ritonavir) darunavir	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Type of PI in Background Regimen (Excluding Ritonavir) lopinavir	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose and up to 12 hours postdose on Day 10

Population: 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.

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=14 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Pharmacokinetic (PK) Parameter: AUCtau of EVG	24028.3 h*ng/mL Standard Deviation 7302.44	—

PRIMARY outcome

Timeframe: Predose and up to 12 hours postdose on Day 10

Population: Intensive PK Analysis Set (EVG)

Cmax is defined as the maximum concentration of drug.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=14 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10	2022.1 ng/mL Standard Deviation 599.94	—

PRIMARY outcome

Timeframe: 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)

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL n=14 Participants 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.)
Percentage of Participants Experiencing Treatment-emergent Adverse Events	100.0 percentage of participants	35.7 percentage of participants

PRIMARY outcome

Population: Safety Analysis Set

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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL n=14 Participants 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.)
Percentage of Participants Experiencing Laboratory Abnormalities Grade 2	35.3 percentage of participants	21.4 percentage of participants
Percentage of Participants Experiencing Laboratory Abnormalities Grade 4	17.6 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Laboratory Abnormalities Grade 1	11.8 percentage of participants	50.0 percentage of participants
Percentage of Participants Experiencing Laboratory Abnormalities Grade 3	35.3 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: Predose and up to 12 hours postdose on Day 10

Population: Intensive PK Analysis Set (EVG)

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=14 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Pharmacokinetic (PK) Parameter: Ctau of EVG	494.3 ng/mL Standard Deviation 261.05	—

SECONDARY outcome

Timeframe: Predose and up to 12 hours postdose on Day 10

Population: Intensive PK Analysis set (EVG)

CL/F is defined as the apparent oral clearance following administration of the drug.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=14 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Pharmacokinetic (PK) Parameter: CL/F of EVG	2863.5 mL/h Standard Deviation 871.07	—

SECONDARY outcome

Timeframe: Predose and up to 12 hours postdose on Day 10

Population: Participants in the Intensive PK Analysis Set: EVG with available data were analyzed.

Vz/F is defined as the apparent volume of distribution of the drug.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=13 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Pharmacokinetic (PK) Parameter: Vz/F of EVG	39508.3 mL Standard Deviation 14071.51	—

SECONDARY outcome

Timeframe: Week 24

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm	76.5 percentage of participants Interval 50.1 to 93.2	—

SECONDARY outcome

Timeframe: Week 48

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm	58.8 percentage of participants Interval 32.9 to 81.6	—

SECONDARY outcome

Timeframe: Week 24

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm	82.4 percentage of participants Interval 56.6 to 96.2	—

SECONDARY outcome

Timeframe: Week 48

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.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm	76.5 percentage of participants Interval 50.1 to 93.2	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=16 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24	-2.44 Log₁₀ copies/mL Standard Deviation 1.132	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=15 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48	-2.23 Log₁₀ copies/ mL Standard Deviation 1.293	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=16 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in CD4 Cell Count at Week 24	77.6 cells/uL Standard Deviation 138.06	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=15 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in CD4 Cell Count at Week 48	131.3 cells/uL Standard Deviation 195.04	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=16 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in CD4 Percentage at Week 24	3.56 percentage (%) Standard Deviation 4.109	—

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: 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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=15 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Change From Baseline in CD4 Percentage at Week 48	5.31 percentage (%) Standard Deviation 5.772	—

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Stage 1	1 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Stage 2	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Stage 4	5 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Stage 5	1 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Missing	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Missing	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Stage 1	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Pubic Hair · Stage 3	4 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Stage 1	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Stage 2	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Stage 3	3 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Stage 4	5 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Stage 5	3 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Female: Breasts · Missing	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Stage 1	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Stage 2	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Stage 3	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Stage 4	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Pubic Hair · Stage 5	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Stage 2	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Stage 3	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Stage 4	0 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Stage 5	2 Participants	—
Tanner Stage Evaluation by Sex at Week 24 Male: Genitalia · Missing	0 Participants	—

SECONDARY outcome

Timeframe: Week 48

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).

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Stage 2	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Stage 3	4 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Stage 4	4 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Missing	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Stage 5	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Missing	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Stage 1	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Stage 5	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Pubic Hair · Missing	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Stage 1	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Stage 2	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Stage 3	2 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Stage 4	5 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Female: Breasts · Stage 5	3 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Stage 1	3 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Stage 2	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Stage 3	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Pubic Hair · Stage 4	1 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Stage 1	2 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Stage 2	2 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Stage 3	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Stage 4	0 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Stage 5	2 Participants	—
Tanner Stage Evaluation by Sex at Week 48 Male: Genitalia · Missing	0 Participants	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

Age of first menses for female participants.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=11 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL 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.)
Age of First Menses	13 years Standard Deviation 1.9	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: Safety Analysis Set

Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100.

Outcome measures

Outcome measures
Measure	Age 6 to < 12 Years n=17 Participants 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).	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL n=14 Participants 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.)
Adherence to EVG	91.1 percentage of pills Standard Deviation 8.94	100.0 percentage of pills Standard Deviation 0.00

Adverse Events

Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL n=17 participants at risk 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.	Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL n=14 participants at risk 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.)
Infections and infestations Bronchitis	5.9% 1/17 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.	0.00% 0/14 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Plasmodium falciparum infection	0.00% 0/17 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.	7.1% 1/14 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Skin candida	5.9% 1/17 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.	0.00% 0/14 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.
Infections and infestations Syphilis	5.9% 1/17 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.	0.00% 0/14 • 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) Safety Analysis Set: all participants who were enrolled and received at least 1 dose of study drug.

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER