Clinical trial NCT03446573: Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
Official title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Switch study
Non-inferiority
Human immunodeficiency virus type 1
Tenofovir alafenamide
Dolutegravir
Lamivudine
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2018-02-27
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized study with parallel group assignment where participants will be randomized into one of the two treatment groups. Participants randomized to DTG + 3TC will receive DTG + 3TC up to Week 200. Participants randomized to TBR will continue to take their current regimen up to Week 148, at which time and if HIV-1 RNA \<50 c/mL at Week 144, these participants will switch to DTG + 3TC up to Week 200. Randomization will be stratified by Baseline third agent class (protease inhibitor \[PI\], integrase inhibitor \[INI\], or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]).
Primary purpose: TREATMENT

Brief summary: The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a \>=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.

This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.


Eligibility criteria: Inclusion Criteria:

* Participant must be able to understand and comply with protocol requirements, instructions, and restrictions;
* Participant must be likely to complete the study as planned;
* Participant must be considered an appropriate candidate for participation in an investigative clinical trial with medication (example no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country).
* Aged 18 years or older (or older where required by local regulatory agencies), at the time of signing the informed consent.
* HIV-1 infected men or women.
* Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
* Plasma HIV-1 RNA \<50 c/mL at Screening.
* Must be on uninterrupted ART for at least 6 months prior to screening. Only the following regimens are allowed:

  * Participant on a TAF-based regimen for at least 6 months as the initial regimen, or
  * Participants who switched from a tenofovir disoproxil fumarate (TDF) first-regimen TAF, without any changes to the other drugs in their regimen, and have been on the TAF-based regimen for at least 3 months immediately prior to Screening i.e., the only switch made is from TDF to TAF. This switch must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for suspected or established treatment failure. A switch from a PI boosted with ritonavir to the same PI boosted with cobicistat is allowed (and vice versa).
* A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test at screen and a negative urine hCG test at randomization \[a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization\]), not lactating, and at least one of the following conditions applies:

  a. Non-reproductive potential defined as:
* Pre-menopausal females with one of the following:

  * Documented tubal ligation
  * Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
  * Hysterectomy
  * Documented bilateral oophorectomy
* Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause \[refer to laboratory reference ranges for confirmatory levels\]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

  b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication.
* The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol. Eligible participants or their legal guardians must sign a written informed consent form before any protocol-specified assessments are conducted.

Participants enrolled in France must be 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, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter (mm)\^3 are NOT exclusionary.
* 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 based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
* Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study, or anticipated need for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment throughout the entire study period.
* Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 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.
* Participants who in the investigator's judgment, poses a significant suicidality 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.
* 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 (IP).
* Use of any regimen consisting of single or dual ART.
* Any evidence of major nucleoside reverse transcriptase inhibitor (NRTI) mutation or presence of any major INSTI resistance-associated mutation in any available prior resistance genotype assay test result, if known, must be provided to ViiV after screening and before randomization for review by ViiV Virology.
* Any verified Grade 4 laboratory abnormality.
* Alanine aminotransferase (ALT) \>=5 times (\*) the upper limit of normal (ULN) or ALT \>=3 \* ULN and bilirubin \>=1.5 \* ULN (with \>35 percent \[%\] direct bilirubin).
* Creatinine clearance of \<50 milliliter (mL)/minute/1.73 meter\^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
* Within the 6 to 12 month window prior to Screening and after confirmed suppression to \<50 c/mL, any plasma HIV-1 RNA measurement \>200 c/mL.
* Within the 6 to 12 month window prior to Screening and after confirmed suppression to \<50 c/mL, 2 or more plasma HIV-1 RNA measurements \>=50 c/mL.
* Within 6 months prior to Screening and after confirmed suppression to \<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement \>=50 c/mL.
* Any drug holiday during the 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
* Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA ≥400 c/mL.
* Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board \[IRB\]) who:

  * Participated in any study using an investigational drug or vaccine 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
  * Participate simultaneously in another clinical study.

Primary outcomes:
measure: Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144
timeFrame: Weeks 96 and 144
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144
timeFrame: Weeks 96 and 144
measure: Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in CD4+ Cell Count at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Number of Participants With Disease Progression at Weeks 24 and 48
timeFrame: At Weeks 24 and 48
measure: Number of Participants With Disease Progression at Weeks 96 and 144
timeFrame: At Weeks 96 and 144
measure: Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148
timeFrame: Up to Week 148
measure: Number of Participants With AEs by Their Severity Grades: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants With AEs by Their Severity Grades: Up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36
timeFrame: Up to Week 36
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 Clinical Chemistry Toxicities: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36
timeFrame: Up to Week 36
measure: Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
timeFrame: Up to Week 144
measure: Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Fasting Lipids at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at weeks 24 and 48
measure: Change From Baseline in Fasting Lipids at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Number of Participants With Genotypic Resistance: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants With Genotypic Resistance: Up to Week 144
timeFrame: Up to Week 144
measure: Number of Participants With Phenotypic Resistance: Up to Week 48
timeFrame: Up to Week 48
measure: Number of Participants With Phenotypic Resistance: Up to Week 144
timeFrame: Up to Week 144
measure: Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
measure: Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
timeFrame: Baseline (Day 1) and at Weeks 24 and 48
measure: Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144
timeFrame: Baseline (Day 1) and at Weeks 96 and 144
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Rialto
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Leandro
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Pierce
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
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: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
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: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Darlinghurst, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Surry Hills
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: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: North Fitzroy
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Prahran
country: Australia
facility: GSK Investigational Site
state: Victoria
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: Brussel
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Toronto
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: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Paris Cedex 13
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Tourcoing cedex
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: München
country: Germany
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Vigo
country: Spain
facility: GSK Investigational Site
state: Galicia
city: Alcala de Henares
country: Spain
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cartagena (Murcia)
country: Spain
facility: GSK Investigational Site
city: Elche
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Granollers (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Huelva
country: Spain
facility: GSK Investigational Site
city: L'Hospitalet de Llobregat
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: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Mataró
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vilajoyosa
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Brighton
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Crumpsall, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.
citation: van Wyk J, Ait-Khaled M, Santos J, Scholten S, Wohlfeiler M, Ajana F, Jones B, Nascimento MC, Tenorio AR, Smith DE, Wright J, Wynne B. Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):794-800. doi: 10.1097/QAI.0000000000002655.