Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:March 27, 2013
End Date:July 18, 2018

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A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and
efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF)
fixed-dose combination (FDC) tablet in treatment-naive and treatment-experienced
HIV-positive, adult participants with mild to moderate renal impairment.

The primary objective of this study is to evaluate the effect of E/C/F/TAF on renal
parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA <
50 copies/mL will also be assessed.

At sites able to conduct the appropriate testing, approximately 30 participants will be
enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the
PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate
(TFV-DP).


Key Inclusion Criteria:

Cohort 1 (treatment-experienced switch)

- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)

- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening

- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight

- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.

Cohort 2 (treatment-naive)

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF

- 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

- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight

All Cohorts:

All subjects must meet all of the following inclusion criteria to be eligible for
participation in this study:

- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures

- CD4+ count of ≥ 50 cells/μL

- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)

- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline

- Normal electrocardiogram (ECG)

- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug

- Female subjects 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

- Male subjects must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or male subjects must be non-heterosexually active, or
practice sexual abstinence

- Age ≥ 18 years

Key Exclusion Criteria:

- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points

- Hepatitis C virus (HCV) antibody positive. Subjects who are HCV positive, but have a
documented negative HCV RNA, are eligible

- Hepatitis B surface antigen (HBVsAg) positive

- Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to
receive treatment for Hepatitis C during the course of the study

- Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)

- 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 subject study compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)

- Subjects receiving ongoing therapy with any medications not to be used with EVG, COBI,
FTC, or TAF or subjects with any known allergies to the excipients of E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
68
sites
Santa Fe, New Mexico 87505
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Aurora, Colorado 80045
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Bellaire, Texas 77401
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Berkley, Michigan 48072
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Beverly Hills, California 90211
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Boston, Massachusetts 02215
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
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Darlinghurst, New South Wales
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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Detroit, Michigan 48202
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Fort Lauderdale, Florida 33316
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1600 Southeast 3rd Avenue
Fort Lauderdale, Florida 33311
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Fort Pierce, Florida 34982
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Gastonia, North Carolina 28054
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Harlingen, Texas 78550
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Hayward, California 94545
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Houston, Texas 77098
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Houston, Texas 77004
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Little Rock, Arkansas 72207
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Long Beach, California 90813
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Macon, Georgia 31220
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Miami, Florida 33133
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Miami Beach, Florida 33139
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Minneapolis, Minnesota 55414
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Neptune, New Jersey 07754
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New Haven, Connecticut 6520
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Newark, New Jersey 07102
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Newport Beach, California 92663
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19104
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85012
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Phoenix, Arizona 85015
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Rochester, New York 14607
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Sacramento, California 95825
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Saint Louis, Missouri 63139
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Saint Louis, Missouri 63108
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San Diego, California 92093
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San Francisco, California 94115
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San Francisco, California 94118
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Seattle, Washington 98104
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Somers Point, New Jersey 08244
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Springfield, Massachusetts 01107
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Washington, District of Columbia 20009
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West Palm Beach, Florida 33401
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Wilton Manors, Florida 33305
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