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Phase 3 Completed N=41 Treatment

Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen

Source: ClinicalTrials.gov NCT02285114 ↗
Enrolled (actual)
41
Serious AEs
12.5%
Results posted
Jan 2021
Primary outcomePrimary: Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF) — 139.9; 200.6 h*ng/mL
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in children and adolescents with HIV-1 who are virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid (RNA) for a period of at least 6 months) while on a stable 2 NRTI containing regimen.

Outcome Measures

OutcomeResultp-value
PRIMARY
Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF)
139.9; 200.6
PRIMARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of TAF
210.8; 220.2
PRIMARY
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24
82.1; 66.7; 66.7; 7.1; 0; 0
SECONDARY
PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
89.1; 139.3; 2259.2; 2320.0; 21.2; 11.6
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV
230.4; 232.0; 2074.4; 2020.0; 55.8; 48.1
SECONDARY
PK Parameter (Cohort 1): Clast of TAF
2.2; 5.5
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Clast of TAF
2.9; 2.1
SECONDARY
PK Parameter (Cohort 1): CL/F of TAF
129.8; 143.4
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): CL/F of TAF
174.3; 102.1
SECONDARY
PK Parameter (Cohort 1): Vz/F of TAF
87.3; 95.3
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Vz/F of TAF
160.8; 63.1
SECONDARY
PK Parameter (Cohort 1): AUCtau of FTC and TFV
14769.9; 14339.8; 415.5; 193.2
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV
12360.8; 11171.7; 999.4; 908.2
SECONDARY
PK Parameter (Cohort 1): Ctau of FTC and TFV
223.4; 301.7; 15.7; 6.7
SECONDARY
PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV
75.4; 75.4; 34.8; 30.9
SECONDARY
Percentage of Participants Experiencing TEAEs and SAEs Through Week 48
89.3; 77.8; 66.7; 7.1; 0; 0
SECONDARY
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
92.9; 100.0; 66.7
SECONDARY
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the US FDA-Defined Snapshot Algorithm
89.3; 77.8; 66.7
SECONDARY
Change From Baseline in CD4+ Cell Count at Week 24
-130; 68; -299
SECONDARY
Change From Baseline in CD4+ Cell Count at Week 48
-105; 210; -124
SECONDARY
Change From Baseline in CD4 Percentage at Week 24
-0.21; 1.29; 0.60
SECONDARY
Change From Baseline in CD4 Percentage at Week 48
-0.20; 0.70; 3.65
SECONDARY
Number of Participants With Palatability of F/TAF Formulation
25; 9; 2; 0; 0; 0
SECONDARY
Number of Participants With Acceptability of F/TAF Formulation
25; 9; 3; 0; 0; 0

Eligibility Criteria

Key Inclusion Criteria

  • Human immunodeficiency virus 1 (HIV-1) infected male and female adolescents and children aged 1 month to < 18 years at baseline/Day 1 (according to requirements of the enrolling cohort)
  • Must be able to give written assent prior to any screening evaluations
  • Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
  • Body weight at screening as follows:
  • Cohort 1: ≥ 35 kg
  • Cohort 2, Group 1: ≥ 25 kg
  • Cohort 2, Group 2: 17 kg to < 25 kg
  • Cohort 3: to be updated per a protocol amendment
  • Cohort 4: to be updated per a protocol amendment
  • Currently on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen that includes a 3rd antiretroviral (ARV) agent for ≥ 6 consecutive months prior to screening
  • Plasma HIV-1 ribonucleic acid (RNA) levels < 50 copies/mL for ≥ 6 consecutive months preceding the screening visit
  • No opportunistic infection within 30 days of study entry (at baseline/Day 1)
  • A negative serum β-human chorionic gonadotropin (HCG) pregnancy test is required for females of childbearing potential only

Key Exclusion Criteria

  • An acquired immunodeficiency syndrome (AIDS) - indicator condition with onset within 30 days prior to screening
  • Life expectancy of < 2 years
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline/Day 1
  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit
  • Active hepatitis C virus (HCV) infection defined as positive for HCV antibody and having detectable HCV RNA
  • Positive hepatitis B surface antigen or other evidence of active hepatitis B virus (HBV) infection.
  • Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, or compliance with the protocol.
  • Pregnant or lactating females
  • Have history of significant drug sensitivity or drug allergy
  • Have previously participated in an investigational trial involving administration of any investigational agent, other than TDF, within 30 days prior to the study dosing

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02285114). 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.

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