Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine



Status:Active, not recruiting
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:7/11/2018
Start Date:August 6, 2012
End Date:November 20, 2018

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

A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppression When Oral GSK1265744 is Combined With Oral Rilpivirine in HIV-1 Infected, Antiretroviral Therapy Naive Adult Subjects

The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral
activity and tolerability in HIV-1 infected, antiretroviral naive subjects.

This study consists of two parts:

Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4
treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of
GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of
open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse
transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either
abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the
Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete
24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1
ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of
virologic rebound) will become eligible for the Maintenance Phase of this study.

Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue
their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily
for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug
ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects
randomized to the EFV arm will continue on their randomized regimen through Week 96.

After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to
continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and
until it is locally approved and commercially available.


Inclusion Criteria:

- HIV-1 infected male or female subjects >= 18 years of age

- Screening plasma HIV-1 RNA >=1000 c/mL

- CD4+ cell count >=200 cells/millimeter (mm)^3

- ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent
following a diagnosis of HIV-1 infection

- Female subjects of child bearing potential are eligible to enter if they are not
pregnant and willing to use protocol-specified methods of contraception to prevent
pregnancy during the study

Exclusion Criteria:

- Any evidence at screening of an active Centers for Disease and Prevention Control
(CDC) Category C disease

- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening

- History of ongoing or clinically relevant hepatitis within the previous 6 months, and
subjects with moderate to severe hepatic impairment will be excluded

- Women who are breastfeeding

- Subject, who in the investigator's judgment, poses a significant suicide risk

- Any clinically significant finding on screening or baseline electrocardiograph (ECG)

- The presence of any specific laboratory abnormalities at Screening

- History of cardiac disease

- Clinically relevant pancreatitis

- Subjects who are unlikely to complete the dosing schedule due to a pre-existing
physical or mental condition

- Any condition which impairs the absorption, distribution, metabolism or excretion of
the investigational product

- Any evidence of primary resistance based upon the presence of a major resistance
associated mutation in the Screening HIV genotype, or any historical genotype

- Treatment with any protocol-specified excluded medication
We found this trial at
40
sites
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Annandale, Virginia 22003
?
mi
from
Annandale, VA
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Buffalo, New York 14263
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80206
?
mi
from
Denver, CO
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
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
Hillsborough, New Jersey 08844
?
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri 64128
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Neptune, New Jersey
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
Oakland Park, Florida 33309
?
mi
from
Oakland Park, FL
Click here to add this to my saved trials
Omaha, Nebraska 68131
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Providence, Rhode Island 02903
?
mi
from
Providence, RI
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Savannah, Georgia 31405
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Valhalla, New York 10595
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
Vancouver, British Columbia
?
mi
from
Vancouver,
Click here to add this to my saved trials
Vero Beach, Florida 32960
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
West Palm Beach, Florida 33409
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials