HIV Infections Clinical Trial
Official title:
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.
n/a
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