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



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:December 14, 2015
End Date:October 2019

Use our guide to learn which trials are right for you!

A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

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 HIV-1 infected adults with end-stage renal disease (ESRD) on chronic
hemodialysis (HD) at Week 48.


Key Inclusion Criteria:

- Currently on a stable antiretroviral regimen for ≥ 6 consecutive months

- Plasma HIV-1 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

- 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 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.
We found this trial at
20
sites
West Palm Beach, Florida 33401
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
598 Telfair Street
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fort Pierce, Florida 34982
?
mi
from
Fort Pierce, FL
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Springfield, Massachusetts 01107
?
mi
from
Springfield, MA
Click here to add this to my saved trials
1 Baumgartner Höhe
Wien, 1140
?
mi
from
Wien,
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials