Phase 3
Completed N=55
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
Source: ClinicalTrials.gov NCT02600819 ↗Enrolled (actual)
55
Serious AEs
60.0%
Results posted
Oct 2018
Primary outcomePrimary: GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 — 32.7 percentage of participants
◆ Published Evidence
Established
33citations · ~4 / year
Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial.
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).
Linked Publications
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Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02600819) 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.