Phase
Condition
Hiv Infections
Hiv/aids
Aids And Aids Related Infections
Treatment
Lamivudine (3TC)
Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
Dolutegravir (DTG)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be an HIV 1 infected adult >=18 years of age (or older, if required by local regulations) at the time of signing the informed consent
An eligible female participant should not be pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at Screening and negative urine test at Baseline), not lactating, and at least one of the following conditions applies
Non reproductive premenopausal women are those that have undergone documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow up confirmation of bilateral tubal occlusion or documented bilateral oophorectomy or hysterectomy
Non reproductive premenopausal women are those with 12 months of spontaneous amenorrhea and >=45 years of age
Women with reproductive potential agree to follow one of the protocol-defined methods for avoiding pregnancy
Should have screening plasma HIV 1 RNA levels of 1000 c/mL to <=100,000 c/mL. If an independent review of accumulated data from other clinical trials investigating the DTG plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen, enrolment will be opened to participants with Screening plasma HIV 1 RNA of 1000 c/mL to <=500,000 c/mL
Participant should be antiretroviral naïve (defined as <=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection). Participants who received HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP dose was >1 year from HIV diagnosis or there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis
Participants or the participants legal representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and the protocol
Participants enrolled in France: a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion Criteria
Women who are breastfeeding or plan to become pregnant or breastfeed during the study
Any evidence of an active centers for disease control and prevention (CDC) Stage 3 disease (CDC, 2014), except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm^3
Participants with severe hepatic impairment (Class C) as determined by Child Pugh classification
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones
Evidence of hepatitis B virus (HBV) infection or HBV surface antibody (anti-HBs or HBsAb) based on:
Participants positive for HBV surface antigen (HBsAg) at screening will be excluded Participants negative for HBV core antibody (anti HBs) but positive for anti HBc (negative HBsAg status) and positive for HBV deoxyribose nucleic acid (DNA) will be excluded; however, participants positive for anti HBc (negative HBsAg status) and positive for anti HBs (past and/or current evidence) are immune to HBV and will not be excluded
Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period
Untreated syphilis infection positive RPR at Screening without clear documentation of treatment. Participants who are at least 14 days post completed treatment are eligible
History or presence of allergy or intolerance 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, anal or penile intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant
Participants who in the Investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide risk
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 systemic immune suppressant
Treatment with any agent, except recognised ART as allowed above, with documented activity against HIV 1 in vitro within 28 days of first dose of study treatment
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 study treatment
Participants enrolled in France: the participant has participated in any study using an investigational drug during the previous 60 days or 5 half lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the participant will participate simultaneously in another clinical study
Any evidence of pre existing viral resistance based on the presence of any major resistance associated mutation in the Screening result or, if known, in any historical resistance test result
Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result
Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participants 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)
Creatinine clearance of <50 mL/min per 1.73 m^2 via the chronic kidney disease epidemiology collaboration (CKD EPI) method
Study Design
Connect with a study center
GSK Investigational Site
Rosario, Santa Fe S2000PBJ
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1425 AWK
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Cordoba, 5000
ArgentinaSite Not Available
GSK Investigational Site
San Isidro, B1642BZA
ArgentinaSite Not Available
GSK Investigational Site
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
GSK Investigational Site
Parramatta, New South Wales 2150
AustraliaSite Not Available
GSK Investigational Site
Melbourne, Victoria Prahran 3181
AustraliaSite Not Available
GSK Investigational Site
North Fitzroy, Victoria 3068
AustraliaSite Not Available
GSK Investigational Site
Prahran, Victoria 3181
AustraliaSite Not Available
GSK Investigational Site
Bruxelles, 1090
BelgiumSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
Lodelinsart, 6042
BelgiumSite Not Available
GSK Investigational Site
Vancouver, British Columbia V6Z 2C7
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2N2
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Bobigny, 93009
FranceSite Not Available
GSK Investigational Site
Lyon, 69317
FranceSite Not Available
GSK Investigational Site
Montpellier Cedex 5, 34295
FranceSite Not Available
GSK Investigational Site
Paris, 75020
FranceSite Not Available
GSK Investigational Site
Paris Cedex 20, 75970
FranceSite Not Available
GSK Investigational Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
GSK Investigational Site
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
GSK Investigational Site
Koeln, Nordrhein-Westfalen 50937
GermanySite Not Available
GSK Investigational Site
Frankfurt/main, 60590
GermanySite Not Available
GSK Investigational Site
Hamburg, 20099
GermanySite Not Available
GSK Investigational Site
München, 81675
GermanySite Not Available
GSK Investigational Site
Modena, Emilia-Romagna 41100
ItalySite Not Available
GSK Investigational Site
Genova, Liguria 16128
ItalySite Not Available
GSK Investigational Site
Milano, Lombardia 20157
ItalySite Not Available
GSK Investigational Site
Torino, Piemonte 10149
ItalySite Not Available
GSK Investigational Site
Bergamo, 24128
ItalySite Not Available
GSK Investigational Site
Monza, 20900
ItalySite Not Available
GSK Investigational Site
Guadalajara, Jalisco 44280
MexicoSite Not Available
GSK Investigational Site
Distrito Federal, 03720
MexicoSite Not Available
GSK Investigational Site
Mexico, 14000
MexicoSite Not Available
GSK Investigational Site
Callao, Callao 02
PeruSite Not Available
GSK Investigational Site
Lima, Callao 2
PeruSite Not Available
GSK Investigational Site
Bydgoszcz, 85-030
PolandSite Not Available
GSK Investigational Site
Amadora, 2720-276
PortugalSite Not Available
GSK Investigational Site
Lisboa, 1349-019
PortugalSite Not Available
GSK Investigational Site
Porto, 4200-319
PortugalSite Not Available
GSK Investigational Site
Bucharest, 021105
RomaniaSite Not Available
GSK Investigational Site
Bucuresti, 30303
RomaniaSite Not Available
GSK Investigational Site
Iasi, 700116
RomaniaSite Not Available
GSK Investigational Site
Izhevsk, 426067
Russian FederationSite Not Available
GSK Investigational Site
Kazan, 420061
Russian FederationSite Not Available
GSK Investigational Site
Kemerovo, 650056
Russian FederationSite Not Available
GSK Investigational Site
Krasnodar, 350015
Russian FederationSite Not Available
GSK Investigational Site
St. Petersburg, 193167
Russian FederationSite Not Available
GSK Investigational Site
St.Peterburg, 190103
Russian FederationSite Not Available
GSK Investigational Site
Alcorcon, 28922
SpainSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Granada, 18014
SpainSite Not Available
GSK Investigational Site
Madrid, 28046
SpainSite Not Available
GSK Investigational Site
Malaga, 29010
SpainSite Not Available
GSK Investigational Site
Marid, 28040
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Bern, 3010
SwitzerlandSite Not Available
GSK Investigational Site
Geneve, CH-1205
SwitzerlandSite Not Available
GSK Investigational Site
Zuerich, 8091
SwitzerlandSite Not Available
GSK Investigational Site
Kaohsiung, 813
TaiwanSite Not Available
GSK Investigational Site
New Taipei, 220
TaiwanSite Not Available
GSK Investigational Site
Taichung, 40705
TaiwanSite Not Available
GSK Investigational Site
Tainan, 704
TaiwanSite Not Available
GSK Investigational Site
Taipei, 11490
TaiwanSite Not Available
GSK Investigational Site
Taoyuan, 330
TaiwanSite Not Available
GSK Investigational Site
Woolwich, London, London SE18 4QH
United KingdomSite Not Available
GSK Investigational Site
Brighton, BN2 5BE
United KingdomSite Not Available
GSK Investigational Site
Liverpool, L69 3GE
United KingdomSite Not Available
GSK Investigational Site
London, E1 1BB
United KingdomSite Not Available
GSK Investigational Site
Manchester, M13 0FH
United KingdomSite Not Available
GSK Investigational Site
Birmingham, Alabama 35294-3300
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 90069
United StatesSite Not Available
GSK Investigational Site
Sacramento, California 95825
United StatesSite Not Available
GSK Investigational Site
San Francisco, California 94109
United StatesSite Not Available
GSK Investigational Site
San Leandro, California 94577
United StatesSite Not Available
GSK Investigational Site
Torrance, California 90502
United StatesSite Not Available
GSK Investigational Site
Aurora, Colorado 80045
United StatesSite Not Available
GSK Investigational Site
Washington, District of Columbia 20005
United StatesSite Not Available
GSK Investigational Site
Washington, D.C., District of Columbia 20005
United StatesSite Not Available
GSK Investigational Site
Fort Pierce, Florida 34982
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33133
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32803
United StatesSite Not Available
GSK Investigational Site
West Palm Beach, Florida 33407
United StatesSite Not Available
GSK Investigational Site
Decatur, Georgia 30033
United StatesSite Not Available
GSK Investigational Site
Savannah, Georgia 31401
United StatesSite Not Available
GSK Investigational Site
Chicago, Illinois 60612
United StatesSite Not Available
GSK Investigational Site
Berkeley, Michigan 48072
United StatesSite Not Available
GSK Investigational Site
Berkley, Michigan 48072
United StatesSite Not Available
GSK Investigational Site
Saint Louis, Missouri 63139
United StatesSite Not Available
GSK Investigational Site
St. Louis, Missouri 63139
United StatesSite Not Available
GSK Investigational Site
Hillsborough, New Jersey 08844
United StatesSite Not Available
GSK Investigational Site
Newark, New Jersey 07102
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45267-0405
United StatesSite Not Available
GSK Investigational Site
Austin, Texas 78705
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75246
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76104
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77009
United StatesSite Not Available
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