Back to results

Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Primary Purpose

Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

E/C/F/TAF

E/C/F/TAF (Low Dose)

About this trial

This is an interventional treatment trial for Acquired Immune Deficiency Syndrome (AIDS) focused on measuring Adolescents, HIV-1, HIV, Treatment-naive, Virologically suppressed

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Cohort 1
- 12 years to < 18 years of age at baseline
- Weight greater than or equal to 35 kg (77 lbs)
- Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
- Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
- No prior use of any approved or experimental anti-HIV-1 drug for any length of time
Cohort 2
- 6 years to < 12 years of age at baseline
- Weight greater than or equal to 25 kg (55 lbs)
- Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
Cohort 3
- Age at baseline: ≥ 2 years old
- Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)
- Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Key Exclusion Criteria:

Hepatitis B or hepatitis C virus infection
Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
Individuals experiencing decompensated cirrhosis
Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Miller's Children Hospital
Children's Research Institute
Emory University School of Medicine
St. Jude Children's Research Hospital
Seattle Children's Hospital
KIDCRU Ward J8
Be Part Yoluntu Centre
Desmond Tutu HIV Foundation
Perinatal HIV Research Unit Baragwanath Hospital
Clinical HIV Research Unit
Empilweni Services and Research Unit (ESRU)
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Queen Savang Vadhana Memorial Hospital
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Joint Clinical Research Centre
University of Zimbabwe - Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg

Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg

Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg

Arm Description

HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age weighing ≥ 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of ≥ 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)

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

PK Parameter: AUCtau of EVG (Cohort 2)

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

PK Parameter: AUCtau of EVG (Cohort 3)

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

PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

PK Parameter: AUClast of TAF (Cohort 2)

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

PK Parameter: AUCtau of TAF (Cohort 3)

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

Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)

Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.

Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.

Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

Secondary Outcome Measures

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)

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

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)

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

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)

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

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)

Cmax is defined as the maximum concentration of drug.

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)

Cmax is defined as the maximum concentration of drug.

PK Parameter: CL of EVG and TAF (Cohort 1)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

PK Parameter: CL of EVG and TAF (Cohort 2)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

PK Parameter: CL of EVG and TAF (Cohort 3)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

PK Parameter: Vz of EVG and TAF (Cohort 1)

Vz is defined as the volume of distribution of the drug after intravenous administration.

PK Parameter: Vz of EVG and TAF (Cohort 2)

Vz is defined as the volume of distribution of the drug after intravenous administration.

PK Parameter: Vz of EVG and TAF (Cohort 3)

Vz is defined as the volume of distribution of the drug after intravenous administration.

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)

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

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)

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

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)

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

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with 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.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with 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.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with 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.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 400 Copies/mL at Weeks 24 and 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.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48

Full Information

NCT ID

NCT01854775

First Posted

May 3, 2013

Last Updated

August 17, 2023

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01854775

Brief Title

Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Official Title

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 6, 2013 (Actual)

Primary Completion Date

May 11, 2020 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Keywords

Adolescents, HIV-1, HIV, Treatment-naive, Virologically suppressed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg

Arm Type

Experimental

Arm Description

Arm Title

Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

E/C/F/TAF

Other Intervention Name(s)

Genvoya®

Intervention Description

Tablets administered orally with food.

Intervention Type

Drug

Intervention Name(s)

E/C/F/TAF (Low Dose)

Intervention Description

90/90/120/6 mg STR administered once daily orally with food.

Primary Outcome Measure Information:

Title

Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: AUCtau of EVG (Cohort 2)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: AUCtau of EVG (Cohort 3)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)

Description

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: AUClast of TAF (Cohort 2)

Description

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: AUCtau of TAF (Cohort 3)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)

Description

Time Frame

From first dose date up to Week 24

Title

Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

Description

Time Frame

From first dose date up to Week 24

Title

Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

Description

Time Frame

From first dose date up to Week 24

Secondary Outcome Measure Information:

Title

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)

Description

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

Time Frame

(pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)

Description

Cmax is defined as the maximum concentration of drug.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)

Description

Cmax is defined as the maximum concentration of drug.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)

Description

Cmax is defined as the maximum concentration of drug.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

PK Parameter: CL of EVG and TAF (Cohort 1)

Description

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: CL of EVG and TAF (Cohort 2)

Description

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: CL of EVG and TAF (Cohort 3)

Description

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

PK Parameter: Vz of EVG and TAF (Cohort 1)

Description

Vz is defined as the volume of distribution of the drug after intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: Vz of EVG and TAF (Cohort 2)

Description

Vz is defined as the volume of distribution of the drug after intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: Vz of EVG and TAF (Cohort 3)

Description

Vz is defined as the volume of distribution of the drug after intravenous administration.

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Title

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Title

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)

Description

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

Time Frame

0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 48

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 48

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 48

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 24

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

Description

Time Frame

Week 48

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Time Frame

Week 48

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Time Frame

Week 48

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Time Frame

Week 48

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.

Time Frame

Week 24

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.

Time Frame

Week 48

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Time Frame

Week 48

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Time Frame

Week 24

Title

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Time Frame

Week 48

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Time Frame

Week 48

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Time Frame

Week 24

Title

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Time Frame

Week 48

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.

Time Frame

Week 24

Title

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

Description

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.

Time Frame

Week 48

Title

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48

Time Frame

Baseline, Week 48

Title

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24

Time Frame

Baseline, Week 24

Title

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48

Time Frame

Baseline, Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Cohort 1 12 years to < 18 years of age at baseline Weight greater than or equal to 35 kg (77 lbs) Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0) Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV) No prior use of any approved or experimental anti-HIV-1 drug for any length of time Cohort 2 6 years to < 12 years of age at baseline Weight greater than or equal to 25 kg (55 lbs) Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR. Cohort 3 Age at baseline: ≥ 2 years old Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs) Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR Key Exclusion Criteria: Hepatitis B or hepatitis C virus infection Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. Individuals experiencing decompensated cirrhosis Pregnant or lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Miller's Children Hospital

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Children's Research Institute

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Emory University School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

St. Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105-0371

Country

United States

Facility Name

KIDCRU Ward J8

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Be Part Yoluntu Centre

City

Cape Town

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Desmond Tutu HIV Foundation

City

Cape Town

ZIP/Postal Code

7705

Country

South Africa

Facility Name

Perinatal HIV Research Unit Baragwanath Hospital

City

Johannesburg

ZIP/Postal Code

1862

Country

South Africa

Facility Name

Clinical HIV Research Unit

City

Johannesburg

ZIP/Postal Code

2041

Country

South Africa

Facility Name

Empilweni Services and Research Unit (ESRU)

City

Johannesburg

ZIP/Postal Code

2092

Country

South Africa

Facility Name

The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Queen Savang Vadhana Memorial Hospital

City

Chon Buri

ZIP/Postal Code

20110

Country

Thailand

Facility Name

Department of Pediatrics, Faculty of Medicine, Khon Kaen University

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Joint Clinical Research Centre

City

Kampala

ZIP/Postal Code

PO Box 10005

Country

Uganda

Facility Name

University of Zimbabwe - Clinical Research Centre

City

Belgravia

ZIP/Postal Code

263

Country

Zimbabwe

12. IPD Sharing Statement

Citations:

Citation

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, et al. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) [Presentation #MOAB0104]. International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention; 2015 19-22 July; Vancouver, Canada.

Results Reference

background

Citation

Rakhmanina N, Gaur A, Natukunda E, Chokephaibulkit K, Liberty A, Kido A, et al. Acceptability and palatability of the single-tablet regimens of B/F/TAF and E/C/F/TAF in children (6-12 years) living with HIV infection [Abstract 33]. 10th International Workshop on HIV Pediatrics; 2018 July 21-22; Amsterdam, The Netherlands

Results Reference

result

Citation

Sharma S, Gupta S, Majeed S, Strehlau R, Hellstrom E, Liu Y, et al. Exposure-Safety of Tenofovir in Pediatric HIV-Infected Participants: Comparison of Tenofovir Alafenamide & Tenofovir Disoproxil Fumarate [Abstract 23]. 10th International Workshop on HIV Pediatrics; 2018 July 21-22; Amsterdam, The Netherlands.

Results Reference

result

PubMed Identifier

30169223

Citation

Natukunda E, Gaur AH, Kosalaraksa P, Batra J, Rakhmanina N, Porter D, Shao Y, Zhang H, Pikora C, Rhee MS. Safety, efficacy, and pharmacokinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial. Lancet Child Adolesc Health. 2017 Sep;1(1):27-34. doi: 10.1016/S2352-4642(17)30009-3. Epub 2017 Jun 29.

Results Reference

result

Citation

Rakhmanina N, Natukunda E, Kosalaraksa P, Batra J, Gaur A, Shao Y, et al. Safety and efficacy of E/C/F/TAF in virologically suppressed, HIV-infected children through 48 weeks [Abstract 32]. 9th International Workshop on HIV Pediatrics; 2017 July 21-22; Paris, France.

Results Reference

result

Citation

Gaur A, Natukunda E, Kosalarksa P, Batra J, Rakhmanina N, Coluci A, et al. Pharmacokinetics, Safety, and Efficacy of E/C/F/TAF in HIV-1-Infected Children (6 to <12 years) [Poster 424]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 February 13-16; Seattle Washington.

Results Reference

result

PubMed Identifier

27765666

Citation

Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N, Rassool M, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, Porter D, Shao Y, Myers M, Ting L, SenGupta D, Quirk E, Rhee MS. Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial. Lancet HIV. 2016 Dec;3(12):e561-e568. doi: 10.1016/S2352-3018(16)30121-7. Epub 2016 Oct 17.

Results Reference

result

Citation

Gaur A, Kizito H, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, et al. Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Treatment-Naive Adolescents [Poster 817]. Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, Massachusetts.

Results Reference

result

Citation

Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim JG, Kaur H, et al. Safety, pharmacokinetics and efficacy of low dose E/C/F/TAF in virologically suppressed children ≥ 2 years old living with HIV. (Abstract OABLB0101) 23rd International AIDS Conference; 06-10 July 2020 (Virtual).

Results Reference

result

Citation

Natukunda E, Liberty A, Strehlau R, Hellstrom E, Hakim J, Kaur H, et al. Safety, pharmacokinetics, and efficacy of low dose E/C/F/TAF in virologically suppressed children ≥ 2 years old living with HIV. (Abstract 3) International Workshop on HIV Pediatrics 2020; 16-17 November 2020 (Virtual).

Results Reference

result

Citation

Liberty A, Strehlau R, Rakhmanina N, Chokephaibulkit K, Koziara J, Kaur H, et al. Acceptability and palatability of low dose B/F/TAF and E/C/F/TAF in children (≥ 2y) with HIV. (Abstract 57) International Workshop on HIV Pediatrics 2020; 16-17 November 2020 (Virtual).

Results Reference

result

Citation

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Poster 953]. Conference on Retroviruses and Opportunistic Infections; 2015 February 23-26; Seattle, WA.

Results Reference

result

Citation

Porter DP, Bennett SR, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs [Poster 952]. Conference on Retroviruses and Opportunistic Infections (CROI); 2015 23-26 February; Seattle, WA.

Results Reference

result

Citation

Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Lawson E, Shao Y, et al. Safety, Efficacy and Pharmacokinetics of the Integrase Inhibitor-Based E/C/F/TAF Single-Tablet Regimen in Treatment-Naïve HIV-Infected Adolescents Through 24 Weeks of Treatment [Poster 36]. 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; 2015 26-28 May; Washington, DC.

Results Reference

result

Links:

URL

https://www.gileadclinicaltrials.com/study/?id=GS-US-292-0106

Description

Gilead Clinical Trials Website

Learn more about this trial

We'll reach out to this number within 24 hrs