HIV
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.
Interventions
DRUGE/C/F/TAF
150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Currently on a stable antiretroviral regimen for ≥ 6 consecutive months * Weight ≥ 35 kg (77 lbs.) * Plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months * CD4+ cell count \> 100 cells/μL * No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV) * Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN) * No evidence of current hepatitis B virus (HBV) infection * No evidence of current hepatitis C virus (HCV) infection Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening. Key
Exclusion criteria
* A new AIDS-defining condition diagnosed within the 30 days prior to Screening * Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening * Pregnant or lactating subjects Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Serious Adverse Events | Up to Week 48 | The percentage of participants experiencing any treatment-emergent serious adverse event was summarized. |
| Incidence of Treatment-Emergent Adverse Events | Up to Week 48 | The percentage of participants experiencing any treatment-emergent adverse event was summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CD4 Cell Count at Week 24 | Baseline; Week 24 | — |
| Change From Baseline in CD4 Cell Count at Week 48 | Baseline; Week 48 | — |
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | Week 24 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient'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. |
| Change From Baseline in CD4 Percentage at Week 48 | Baseline; Week 48 | — |
| Change From Baseline in CD4 Percentage at Week 24 | Baseline; Week 24 | — |
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | Week 48 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. |
Countries
South Africa, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in South Africa and the United States. The first participant was screened on 03 December 2014. The last study visit occurred on 23 October 2017.
Pre-assignment details
68 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age | 50 |
| E/C/F/TAF (≥ 18 Years of Age) E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older | 10 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrew Consent | 1 | 0 |
Baseline characteristics
| Characteristic | E/C/F/TAF (≥ 18 Years of Age) | E/C/F/TAF (12 - 17 Years of Age) | Total |
|---|---|---|---|
| Age, Continuous | 19 years STANDARD_DEVIATION 1.2 | 15 years STANDARD_DEVIATION 1.6 | 16 years STANDARD_DEVIATION 2.2 |
| CD4 Cell Count | 776 cells/µL STANDARD_DEVIATION 179.9 | 753 cells/µL STANDARD_DEVIATION 222.5 | 757 cells/µL STANDARD_DEVIATION 214.8 |
| CD4 Percentage | 35.9 percentage STANDARD_DEVIATION 6.53 | 34.3 percentage STANDARD_DEVIATION 6.72 | 34.6 percentage STANDARD_DEVIATION 6.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 49 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV-1 RNA Category < 50 copies/mL | 9 Participants | 49 Participants | 58 Participants |
| HIV-1 RNA Category ≥ 50 copies/mL | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 9 Participants | 49 Participants | 58 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment South Africa | 10 Participants | 42 Participants | 52 Participants |
| Region of Enrollment United States | 0 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 32 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 10 |
| other Total, other adverse events | 42 / 50 | 10 / 10 |
| serious Total, serious adverse events | 3 / 50 | 0 / 10 |
Outcome results
Primary
Incidence of Treatment-Emergent Adverse Events
The percentage of participants experiencing any treatment-emergent adverse event was summarized.
Time frame: Up to Week 48
Population: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Incidence of Treatment-Emergent Adverse Events | 92.0 percentage of participants |
| E/C/F/TAF (≥ 18 Years of Age) | Incidence of Treatment-Emergent Adverse Events | 100.0 percentage of participants |
Primary
Incidence of Treatment-Emergent Serious Adverse Events
The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Time frame: Up to Week 48
Population: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Incidence of Treatment-Emergent Serious Adverse Events | 4.0 percentage of participants |
| E/C/F/TAF (≥ 18 Years of Age) | Incidence of Treatment-Emergent Serious Adverse Events | 0 percentage of participants |
Secondary
Change From Baseline in CD4 Cell Count at Week 24
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Change From Baseline in CD4 Cell Count at Week 24 | -72 cells/µL | Standard Deviation 189.8 |
| E/C/F/TAF (≥ 18 Years of Age) | Change From Baseline in CD4 Cell Count at Week 24 | -85 cells/µL | Standard Deviation 245.9 |
Secondary
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Change From Baseline in CD4 Cell Count at Week 48 | -43 cells/µL | Standard Deviation 201.1 |
| E/C/F/TAF (≥ 18 Years of Age) | Change From Baseline in CD4 Cell Count at Week 48 | -41 cells/µL | Standard Deviation 143 |
Secondary
Change From Baseline in CD4 Percentage at Week 24
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Change From Baseline in CD4 Percentage at Week 24 | -0.6 percentage | Standard Deviation 5.46 |
| E/C/F/TAF (≥ 18 Years of Age) | Change From Baseline in CD4 Percentage at Week 24 | -0.6 percentage | Standard Deviation 5.46 |
Secondary
Change From Baseline in CD4 Percentage at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Change From Baseline in CD4 Percentage at Week 48 | -0.1 percentage | Standard Deviation 3.95 |
| E/C/F/TAF (≥ 18 Years of Age) | Change From Baseline in CD4 Percentage at Week 48 | -1.1 percentage | Standard Deviation 7.29 |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient'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
Population: Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | 96.0 percentage of participants |
| E/C/F/TAF (≥ 18 Years of Age) | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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
Population: Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E/C/F/TAF (12 - 17 Years of Age) | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | 90.0 percentage of participants |
| E/C/F/TAF (≥ 18 Years of Age) | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | 100.0 percentage of participants |