Clinical trial NCT02831673: An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)
Official title: A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Human Immunodeficiency Virus
HIV Infections
Keywords: safety
treatment naïve
HIV 1
dolutegravir plus lamivudine
non inferiority
tolerability
dolutegravir plus tenofovir/emtricitabine
efficacy
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: GlaxoSmithKline
First posted: 2016-07-13
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir \[TDF\]/Emtricitabine \[FTC\] fixed dose combination \[FDC\]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult participants that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 participants will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.


Eligibility criteria: 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
* Participants 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
* Participant 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 B 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

Primary outcomes:
measure: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
timeFrame: Week 144
measure: Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
timeFrame: Up to Week 144
measure: CD4+ Cell Counts at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: CD4+ Cell Counts at Week 96
timeFrame: Week 96
measure: CD4+ Cell Counts at Week 144
timeFrame: Week 144
measure: Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
timeFrame: Baseline (Day 1) and Weeks 24, 48
measure: Changes From Baseline in CD4+ Cell Counts at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Changes From Baseline in CD4+ Cell Counts at Week 144
timeFrame: Baseline (Day 1) and Week 144
measure: Number of Participants With HIV-1 Disease Progression up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Any AE and SAE up to Week 148
timeFrame: Up to Week 148
measure: Number of Participants With AEs by Maximum Severity Grades up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
timeFrame: Up to Week 24, Week 48 and Week 96
measure: Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
timeFrame: Up to Week 144
measure: Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Change From Baseline in Renal Biomarker-Serum RBP at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Renal Biomarker-Serum RBP at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
timeFrame: Baseline (Day 1) and Week 144
measure: Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
timeFrame: Baseline (Day 1) and at Weeks 24, 48
measure: Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
timeFrame: Baseline (Day 1) and at Week 96
measure: Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
timeFrame: Baseline (Day 1) and at Week 144
measure: Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
timeFrame: Weeks 24 and Week 48
measure: Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
timeFrame: Week 96
measure: Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
timeFrame: Week 144
measure: Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
timeFrame: Week 24
measure: Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
timeFrame: Week 48
measure: Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
timeFrame: Week 144
measure: Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
timeFrame: Baseline (Day 1) and Week 24
measure: Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
timeFrame: Baseline (Day 1) and Week 48
measure: Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
timeFrame: Baseline (Day 1) and Week 96
measure: Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
timeFrame: Baseline (Day 1) and Week 144
measure: Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
timeFrame: Baseline (Day 1) and Weeks 4, 24, 48
measure: Change From Baseline in EQ-5D-5L Utility Score at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Change From Baseline in EQ-5D-5L Utility Score at Week 144
timeFrame: Baseline (Day 1) and Week 144
measure: Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
timeFrame: Baseline (Day 1) and Weeks 4, 24, 48
measure: Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
timeFrame: Baseline (Day 1) and Week 96
measure: Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
timeFrame: Baseline (Day 1) and Week 144
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Pierce
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Springfield
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Berkley
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Fortitude Valley
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Le Kremlin-Bicetre Cedex
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Busto Arsizio (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Padova
country: Italy
facility: GSK Investigational Site
city: Reggio Emilia
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Distrito Federal
country: Mexico
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Coimbra
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Krasnojarsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Orel
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Toliyatti
country: Russian Federation
facility: GSK Investigational Site
city: Observatory, Cape Town
country: South Africa
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Córdoba
country: Spain
facility: GSK Investigational Site
city: Elche (Alicante)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Mataró
country: Spain
facility: GSK Investigational Site
city: San Sebastian
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo
country: Spain
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.
citation: Ait-Khaled M, Sierra Madero J, Estrada V, Gulminetti R, Hagins D, Tsai HC, Man C, Sievers J, Grove R, Zolopa A, Wynne B, van Wyk J. Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies. HIV Res Clin Pract. 2021 Dec 9;23(1):9-14. Epub 2021 Dec 16.