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:2/4/2017
Start Date:August 2012
End Date:December 2020

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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
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Albany, New York 12206
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Annandale, Virginia 22003
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Atlanta, Georgia 30341
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Augusta, Georgia 30909
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Austin, Texas 78705
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Bakersfield, California 93309
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Beverly Hills, California 90211
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Birmingham, Alabama 35249
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Boston, Massachusetts 02115
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Boston, MA
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Buffalo, New York 14263
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29425
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Dallas, Texas 75230
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Denver, Colorado 80206
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Fort Lauderdale, Florida 33308
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Fort Pierce, Florida 34982
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Hillsborough, New Jersey 08844
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Kansas City, Missouri 64128
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72205
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Long Beach, California 90813
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Los Angeles, California 90025
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Macon, Georgia 31201
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Miami, Florida 33136
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Minneapolis, Minnesota 55404
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Neptune, New Jersey
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New York, New York 10032
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Omaha, Nebraska 68131
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Orlando, Florida 32806
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Phoenix, Arizona 85012
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Providence, Rhode Island 02903
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San Francisco, California 94115
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Savannah, Georgia 31405
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Valhalla, New York 10595
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Vancouver, British Columbia
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Vero Beach, Florida 32960
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Washington, District of Columbia 20007
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Washington,
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West Palm Beach, Florida 33409
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Wilton Manor, Florida 33305
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