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Phase 3 N=55 Treatment

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

HIV-1 Infection

Enrolled (actual)
55
Serious AEs
60.0%
Results posted
Oct 2018
Primary outcome: Primary: GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 — 32.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
E/C/F/TAF (Drug); B/F/TAF (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Gilead Sciences
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48
32.7
SECONDARY
GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96
43.6
SECONDARY
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm
87.3
SECONDARY
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm
81.8
SECONDARY
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm
54.5
SECONDARY
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)
14284.8; 10179.5; 62929.9; 8715.0
SECONDARY
PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV
12857.6; 9558.7; 59057.4; 231.9; 7664.2
SECONDARY
PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV
1258.5; 1370.4; 4875.0; 246.3; 442.8
SECONDARY
PK Parameter: Ctau of EVG, COBI, FTC, and TFV
174.4; 28.9; 1277.3; 264.8
SECONDARY
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach
61.8
SECONDARY
GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach
100.0
SECONDARY
BVY OL Extension Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
100.0
SECONDARY
GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96
-35
SECONDARY
BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48
581; -104
SECONDARY
GEN Phase: Change From Baseline in CD4 Percentage at Week 96
2.8
SECONDARY
BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48
31.9; 1.7

Summary

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).

Eligibility Criteria

Key Inclusion Criteria

  • Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
  • Plasma HIV-1 ribonucleic acid (RNA) concentrations < 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
  • No documented history of HIV-1 resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV) and no history of switching off EVG, FTC, 3TC or TFV due to concern for resistance
  • Cluster determinant 4 (CD4+) T cell count ≥ 200 cells/μL
  • ESRD with estimated glomerular filtration rate (eGFR) < 15 mL/min by Cockcroft-Gault formula for creatinine clearance
  • On chronic HD for ≥ 6 months prior to screening
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

Key Exclusion Criteria

  • Hepatitis B co-infection
  • Any clinical history, condition, or test result that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Administration of other investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial.
  • History or presence of allergy or intolerance to the study drugs or their components
  • A new acquired immunodeficiency syndrome (AIDS)-defining condition (excluding CD4+ T cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis
  • Received solid organ or bone marrow transplant

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02600819). 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.

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