Phase 3
Completed N=872
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
Source: ClinicalTrials.gov NCT01780506 ↗Enrolled (actual)
872
Serious AEs
13.2%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 — 93.1; 92.8 percentage of participants — p=0.78
Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 |
93.1; 92.8 | 0.78 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 |
89.2; 88.2; 86.9; 83.1 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 |
86.4; 87.3; 84.4; 83.6; 84.6; 80.1 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
235; 221 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 |
285; 271 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 144 |
323; 310 | — |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 |
-0.865; -3.200 | — |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 96 |
-0.951; -3.515 | — |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 144 |
-0.826; -3.475 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
-1.337; -2.956 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 96 |
-0.907; -3.053 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 144 |
-0.809; -3.023 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 48 |
0.08; 0.11 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 96 |
0.05; 0.07 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 144 |
0.04; 0.08 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48 |
25.8; 32.3; 4.6; 4.9; 0; 0.2 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96 |
28.8; 33.9; 5.1; 5.8; 0.2; 0.2 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144 |
31.3; 37.1; 6.0; 7.0; 0.2; 0.2 | — |
| SECONDARY Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 |
6.9; 51.2 | — |
| SECONDARY Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 |
11.3; 75.0 | — |
| SECONDARY Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144 |
37.4; 106.9 | — |
| SECONDARY Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 |
-32.8; 18.0 | — |
| SECONDARY Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 |
-33.5; 32.5 | — |
| SECONDARY Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144 |
-24.6; 60.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Plasma HIV-1 RNA levels ≥ 1, 000 copies/mL at screening
- No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening
- Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
- Normal electrocardiogram (ECG)
- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
Key Exclusion Criteria
- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive
- Individuals experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
- History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Participation in any other clinical trial (including observational trials) without prior approval
- Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01780506). 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.