Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
NCT ID: NCT01449929
Last Updated: 2018-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
488 participants
INTERVENTIONAL
2011-10-31
2016-12-26
Brief Summary
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Detailed Description
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Subjects who fulfil eligibility requirements will be randomized 1:1 to receive DTG 50 mg once daily or DRV/r 800 mg/100 mg once daily. In order to achieve balance across the two treatment groups of the study, randomization will be stratified by: screening plasma HIV-1 RNA \>/ 100,000 copies/mL (c/mL) or \> 100,000 c/mL and background dual NRTI (ABC/3TC or TDF/FTC) The DTG and DRV/r doses will be administered in an open-label fashion throughout the study.
Subjects randomized to receive DTG and who successfully complete 96 weeks of treatment will continue to have access to DTG until either it is locally approved and commercially available, the patient no longer derives clinical benefit, the patient meets a protocol-defined reason for discontinuation or until development of DTG is terminated. Subjects randomized to the DRV/r arm will receive DRV/r through their Week 96 visit, after which they will be discontinued from the study and will need to make alternative arrangements to access antiretroviral medication. All subjects will receive background dual-NRTI therapy through their Week 96 visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dolutegravir 50mg once daily (OAD)
in combination with either abacavir/lamivudine fixed dose combination tablet OAD or tenofovir disoproxil fumarate/emtricitabline fixed dose combination tablet OAD
dolutegravir 50 mg OAD
1 x 50 mg tablet OAD
darunavir 800mg OAD in combination with ritonavir 100mg OAD
in combination with either abacavir/lamivudine fixed dose combination tablet OAD or tenofovir disoproxil fumarate/emtricitabline fixed dose combination tablet OAD
darunavir 800mg OAD
2 x 400mg tablets OAD
ritonavir 100mg OAD
1 x 100mg tablet OAD
Interventions
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dolutegravir 50 mg OAD
1 x 50 mg tablet OAD
darunavir 800mg OAD
2 x 400mg tablets OAD
ritonavir 100mg OAD
1 x 100mg tablet OAD
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL
* Antiretroviral-naïve (less than or equal to 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
Exclusion Criteria
* Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease \[CDC, 1993\], except cutaneous Kaposi's sarcoma not requiring systemic therapy
* Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification
* Anticipated need for Hepatitis C virus (HCV) therapy during the study
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
* Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators
* Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
* Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product
* Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation \[IAS-USA, 2010\] in the Screening result or, if known, any historical resistance test result
* Any verified Grade 4 laboratory abnormality. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound is exclusionary
* Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
* ALT greater than 3 times the upper limit of normal and bilirubin greater than or equal to 1.5 times the upper limit of normal (with greater than 35% direct bilirubin)
* Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method
* Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
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
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Norwalk, Connecticut, 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
Washington D.C., District of Columbia, United States
GSK Investigational Site
Daytona Beach, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Vero Beach, Florida, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Macon, Georgia, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Springfield, Massachusetts, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Providence, Rhode Island, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Longview, Texas, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Saint-Denis, , France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Modena, Emilia-Romagna, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Turin, Piedmont, Italy
GSK Investigational Site
Ponce, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Constanța, , Romania
GSK Investigational Site
Krasnodar, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saratov, , Russia
GSK Investigational Site
Volgograd, , Russia
GSK Investigational Site
Badalona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Lausanne, , Switzerland
GSK Investigational Site
Zurich, , Switzerland
Countries
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References
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Molina JM, Clotet B, van Lunzen J, Lazzarin A, Cavassini M, Henry K, Kulagin V, Givens N, de Oliveira CF, Brennan C; FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015 Apr;2(4):e127-36. doi: 10.1016/S2352-3018(15)00027-2. Epub 2015 Mar 10.
Clotet B, Feinberg J, van Lunzen J, Khuong-Josses MA, Antinori A, Dumitru I, Pokrovskiy V, Fehr J, Ortiz R, Saag M, Harris J, Brennan C, Fujiwara T, Min S; ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014 Jun 28;383(9936):2222-31. doi: 10.1016/S0140-6736(14)60084-2. Epub 2014 Apr 1.
Other Identifiers
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114915
Identifier Type: -
Identifier Source: org_study_id
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