Phase 3
Completed N=129
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
Acquired Immune Deficiency Syndrome (AIDS) · HIV
Source: ClinicalTrials.gov NCT01854775 ↗
Enrolled (actual)
129
Serious AEs
14.0%
Results posted
May 2021
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) — 23840.1 hr*ng/mL
◆ Published Evidence
Established
41citations · ~4 / year
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.
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 (Part A), and to evaluate the safety and tolerability of E/C/F/TAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to = 25 kg.
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.
Linked Publications (4)
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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.
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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.
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Longitudinal Evaluation of Bone Safety in Children and Adolescents With HIV-1 Starting Tenofovir Alafenamide-Containing Antiretroviral Therapy.
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Pharmacokinetics, safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in children with HIV aged from 2 years and weighing at least 14 kg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) |
23840.1 | — |
| PRIMARY PK Parameter: AUCtau of EVG (Cohort 2) |
33813.9 | — |
| PRIMARY PK Parameter: AUCtau of EVG (Cohort 3) |
33245.6 | — |
| PRIMARY PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) |
188.9 | — |
| PRIMARY PK Parameter: AUClast of TAF (Cohort 2) |
332.9 | — |
| PRIMARY PK Parameter: AUCtau of TAF (Cohort 3) |
366.4 | — |
| PRIMARY Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) |
81.3; 8.3 | — |
| PRIMARY Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs |
73.9; 0 | — |
| PRIMARY Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs |
70.4; 3.7 | — |
| SECONDARY PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) |
300.8; 102.4; 10.0; 25.0 | — |
| SECONDARY PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) |
370.0; 114.9; 15.1; 96.0 | — |
| SECONDARY PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) |
277.5; 82.5; 11.4; 23.0 | — |
| SECONDARY PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) |
2229.6; 166.8; 2265.0; 17.6; 1202.4 | — |
| SECONDARY PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) |
3055.2; 313.3; 3397.4; 26.1; 2079.4 | — |
| SECONDARY PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) |
3297.2; 286.6; 3007.4; 19.6; 1525.5 | — |
| SECONDARY PK Parameter: CL/F of EVG and TAF (Cohort 1) |
6.7; 68.6 | — |
| SECONDARY PK Parameter: CL/F of EVG and TAF (Cohort 2) |
6.3; 31.9 | — |
| SECONDARY PK Parameter: CL/F of EVG and TAF (Cohort 3) |
3.4; 18.5 | — |
| SECONDARY PK Parameter: Vz/F of EVG and TAF (Cohort 1) |
60.5; 49.7 | — |
| SECONDARY PK Parameter: Vz/F of EVG and TAF (Cohort 2) |
46.8; 28.6 | — |
| SECONDARY PK Parameter: Vz/F of EVG and TAF (Cohort 3) |
28.5; 16.3 | — |
| SECONDARY PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) |
14424.4; 287.6; 8240.8 | — |
| SECONDARY PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) |
20629.2; 440.2; 15890.7 | — |
| SECONDARY PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) |
19468.1; 334.9; 14485.2 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis |
90.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis |
92.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis |
94.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis |
94.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis |
98.1 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis |
96.3 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis |
96.3 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses |
90.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses |
92.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses |
94.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses |
94.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses |
100.0 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses |
96.3 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses |
96.3 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses |
93.8 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses |
95.8 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses |
97.9 | — |
| SECONDARY Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses |
97.9 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses |
100.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses |
100.0 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses |
96.3 | — |
| SECONDARY Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses |
96.3 | — |
| SECONDARY Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 |
4.62; -3.25 | — |
| SECONDARY Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 |
4.62; -3.26 | — |
| SECONDARY Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 |
471; 191 | — |
| SECONDARY Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 |
471; 224 | — |
| SECONDARY Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 |
961; -118 | — |
| SECONDARY Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 |
961; -66 | — |
| SECONDARY Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 |
1153; -137 | — |
| SECONDARY Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 |
1153; -179 | — |
| SECONDARY Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 |
23.6; 7.7 | — |
| SECONDARY Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 |
23.6; 9.3 | — |
| SECONDARY Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 |
38.2; -0.8 | — |
| SECONDARY Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 |
38.2; -0.6 | — |
| SECONDARY Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 |
35.9; 0.0 | — |
| SECONDARY Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 |
35.9; 0.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Cohort 1
- Age at baseline: 12 years to 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 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.
Data sourced from ClinicalTrials.gov (NCT01854775) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.