A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
NCT ID: NCT01910402
Last Updated: 2024-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
499 participants
INTERVENTIONAL
2013-08-22
2022-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DTG/ABC/3TC FDC
As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food
Dolutegravir/abacavir/lamivudine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
ATV +RTV +TDF/FTC FDC
As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food
Atazanavir
Atazanavir capsule 300 mg
Ritonavir
Ritonavir tablet 100 mg
Tenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
Interventions
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Dolutegravir/abacavir/lamivudine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
Atazanavir
Atazanavir capsule 300 mg
Ritonavir
Ritonavir tablet 100 mg
Tenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
Eligibility Criteria
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Inclusion Criteria
* Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
* HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=500 c/mL.
* Documentation that the subject is negative for the HLA-B\*5701 allele.
* Antiretroviral-naïve (\<=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
* Women who plan to become pregnant during the first 48 weeks of the study
* Any subject who has had a medical intervention for gender reassignment
* Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
* Subjects with any degree of hepatic impairment
* Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
* History or presence of allergy to the study drugs or their components or drugs of their class
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
* poses a significant suicidality risk
* History of osteoporosis with fracture or requiring pharmacologic therapy
* 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 that alter immune responses;
* Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)
* 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 IP
* Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result
* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)
* 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
* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin)
* Subject has CrCL of \<50 mL/min via Cockroft-Gault method
* Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.
18 Years
FEMALE
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
Phoenix, Arizona, United States
GSK Investigational Site
Bakersfield, California, United States
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Beverly Hills, California, United States
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Washington D.C., District of Columbia, United States
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Ft. Pierce, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Indianapolis, Indiana, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Neptune City, New Jersey, United States
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Newark, New Jersey, United States
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Buffalo, New York, United States
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Valhalla, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Lynchburg, Virginia, United States
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Bobigny, , France
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Nantes, , France
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Paris, , France
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Genoa, Liguria, Italy
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Bergamo, Lombardy, Italy
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Brescia, Lombardy, Italy
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Busto Arsizio (VA), Lombardy, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Turin, Piedmont, Italy
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Guadalajara, Jalisco, Mexico
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México, , Mexico
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Amadora, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Ponce, , Puerto Rico
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Rio Piedras, , Puerto Rico
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San Juan, , Puerto Rico
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Moscow, , Russia
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Oryol, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Toliyatti, , Russia
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Observatory, Cape Town, Western Province, South Africa
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Mamelodi East, , South Africa
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(Móstoles) Madrid, , Spain
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Alicante, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Murcia, , Spain
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Seville, , Spain
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Bangkok, , Thailand
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Nonthaburi, , Thailand
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Birmingham, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
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Tooting, London, , United Kingdom
Countries
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References
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Orrell C, Hagins DP, Belonosova E, Porteiro N, Walmsley S, Falco V, Man CY, Aylott A, Buchanan AM, Wynne B, Vavro C, Aboud M, Smith KY; ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017 Dec;4(12):e536-e546. doi: 10.1016/S2352-3018(17)30095-4. Epub 2017 Jul 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-005823-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
117172
Identifier Type: -
Identifier Source: org_study_id
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