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
NCT ID: NCT01641809
Last Updated: 2020-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
244 participants
INTERVENTIONAL
2012-08-06
2019-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 GSK1265744 10 mg
In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
GSK1265744 10 mg
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Placebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Arm 2 GSK1265744 30 mg
In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
GSK1265744 30 mg
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Placebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Arm 3 GSK1265744 60 mg
In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96.
GSK1265744 60 mg
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Arm 4 Efavirenz 600 mg
In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine).
Efavirenz 600 mg
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Interventions
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GSK1265744 10 mg
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
GSK1265744 30 mg
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
GSK1265744 60 mg
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Efavirenz 600 mg
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Placebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Ft. Pierce, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Oakland Park, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Macon, Georgia, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Hillsborough, New Jersey, United States
GSK Investigational Site
Neptune City, New Jersey, United States
GSK Investigational Site
Albany, New York, United States
GSK Investigational Site
Buffalo, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Valhalla, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Providence, Rhode Island, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Annandale, Virginia, United States
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
Countries
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References
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Mills A, Richmond GJ, Newman C, Osiyemi O, Cade J, Brinson C, De Vente J, Margolis DA, Sutton KC, Wilches V, Hatch S, Roberts J, McCoig C, Garris C, Vandermeulen K, Spreen WR. Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. AIDS. 2022 Feb 1;36(2):195-203. doi: 10.1097/QAD.0000000000003085.
Patel P, Xue Z, King KS, Parham L, Ford S, Lou Y, Bakshi KK, Sutton K, Margolis D, Hughes AR, Spreen WR. Evaluation of the effect of UGT1A1 polymorphisms on the pharmacokinetics of oral and long-acting injectable cabotegravir. J Antimicrob Chemother. 2020 Aug 1;75(8):2240-2248. doi: 10.1093/jac/dkaa147.
Margolis DA, Brinson CC, Smith GHR, de Vente J, Hagins DP, Eron JJ, Griffith SK, Clair MHS, Stevens MC, Williams PE, Ford SL, Stancil BS, Bomar MM, Hudson KJ, Smith KY, Spreen WR; LAI116482 Study Team. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Lancet Infect Dis. 2015 Oct;15(10):1145-1155. doi: 10.1016/S1473-3099(15)00152-8. Epub 2015 Jul 19.
Other Identifiers
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116482
Identifier Type: -
Identifier Source: org_study_id
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