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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03446573

Registration number

NCT03446573

Ethics application status

Date submitted

5/01/2018

Date registered

27/02/2018

Date last updated

19/07/2023

Titles & IDs

Public title

Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

Scientific 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

Secondary ID [1]

2015-004401-17

Secondary ID [2]

204862

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

HIV Infections

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - DTG + 3TC
Treatment: Drugs - TAF based regimen (TBR)

Experimental: DTG + 3TC 50 mg/300 mg - Participants will receive a single tablet of a two-drug regimen of DTG 50 mg + 3TC 300 mg once daily from Day 1 through Week 200 (Early and Late Switch Phase).

Active comparator: TAF based regimen (TBR) - Participants will continue their TBR from Day 1 to Week 148 (Early Switch Phase), and eligible participants will switch to DTG + 3TC once daily from Week 148 to 200 (Late Switch Phase).

Treatment: Drugs: DTG + 3TC
DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.

Treatment: Drugs: TAF based regimen (TBR)
Participants will continue to receive their TBR.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48

Timepoint [1]

Week 48

Secondary outcome [1]

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48

Timepoint [1]

Week 48

Secondary outcome [2]

Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24

Timepoint [2]

Week 24

Secondary outcome [3]

Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144

Timepoint [3]

Weeks 96 and 144

Secondary outcome [4]

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24

Timepoint [4]

Week 24

Secondary outcome [5]

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144

Timepoint [5]

Weeks 96 and 144

Secondary outcome [6]

Change From Baseline in CD4+ Cell Count at Weeks 24 and 48

Timepoint [6]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [7]

Change From Baseline in CD4+ Cell Count at Weeks 96 and 144

Timepoint [7]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [8]

Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48

Timepoint [8]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [9]

Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144

Timepoint [9]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [10]

Number of Participants With Disease Progression at Weeks 24 and 48

Timepoint [10]

At Weeks 24 and 48

Secondary outcome [11]

Number of Participants With Disease Progression at Weeks 96 and 144

Timepoint [11]

At Weeks 96 and 144

Secondary outcome [12]

Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48

Timepoint [12]

Up to Week 48

Secondary outcome [13]

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48

Timepoint [13]

Up to Week 48

Secondary outcome [14]

Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148

Timepoint [14]

Up to Week 148

Secondary outcome [15]

Number of Participants With AEs by Their Severity Grades: Up to Week 48

Timepoint [15]

Up to Week 48

Secondary outcome [16]

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48

Timepoint [16]

Up to Week 48

Secondary outcome [17]

Number of Participants With AEs by Their Severity Grades: Up to Week 144

Timepoint [17]

Up to Week 144

Secondary outcome [18]

Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48

Timepoint [18]

Up to Week 48

Secondary outcome [19]

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48

Timepoint [19]

Up to Week 48

Secondary outcome [20]

Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144

Timepoint [20]

Up to Week 144

Secondary outcome [21]

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48

Timepoint [21]

Up to Week 48

Secondary outcome [22]

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36

Timepoint [22]

Up to Week 36

Secondary outcome [23]

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144

Timepoint [23]

Up to Week 144

Secondary outcome [24]

Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48

Timepoint [24]

Up to Week 48

Secondary outcome [25]

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36

Timepoint [25]

Up to Week 36

Secondary outcome [26]

Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144

Timepoint [26]

Up to Week 144

Secondary outcome [27]

Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48

Timepoint [27]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [28]

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

Timepoint [28]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [29]

Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144

Timepoint [29]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [30]

Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48

Timepoint [30]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [31]

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

Timepoint [31]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [32]

Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144

Timepoint [32]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [33]

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48

Timepoint [33]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [34]

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

Timepoint [34]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [35]

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144

Timepoint [35]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [36]

Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48

Timepoint [36]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [37]

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

Timepoint [37]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [38]

Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144

Timepoint [38]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [39]

Change From Baseline in Fasting Lipids at Weeks 24 and 48

Timepoint [39]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [40]

Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

Timepoint [40]

Baseline (Day 1) and at weeks 24 and 48

Secondary outcome [41]

Change From Baseline in Fasting Lipids at Weeks 96 and 144

Timepoint [41]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [42]

Number of Participants With Genotypic Resistance: Up to Week 48

Timepoint [42]

Up to Week 48

Secondary outcome [43]

Number of Participants With Genotypic Resistance: Up to Week 144

Timepoint [43]

Up to Week 144

Secondary outcome [44]

Number of Participants With Phenotypic Resistance: Up to Week 48

Timepoint [44]

Up to Week 48

Secondary outcome [45]

Number of Participants With Phenotypic Resistance: Up to Week 144

Timepoint [45]

Up to Week 144

Secondary outcome [46]

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

Timepoint [46]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [47]

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

Timepoint [47]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [48]

Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144

Timepoint [48]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [49]

Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48

Timepoint [49]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [50]

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

Timepoint [50]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [51]

Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144

Timepoint [51]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [52]

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48

Timepoint [52]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [53]

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

Timepoint [53]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [54]

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144

Timepoint [54]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [55]

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

Timepoint [55]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [56]

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

Timepoint [56]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [57]

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

Timepoint [57]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [58]

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48

Timepoint [58]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [59]

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

Timepoint [59]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [60]

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144

Timepoint [60]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [61]

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48

Timepoint [61]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [62]

Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144

Timepoint [62]

Baseline (Day 1) and at Weeks 96 and 144

Secondary outcome [63]

Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48

Timepoint [63]

Baseline (Day 1) and at Weeks 24 and 48

Secondary outcome [64]

Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144

Timepoint [64]

Baseline (Day 1) and at Weeks 96 and 144

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

18/01/2018

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

3/05/2022

Sample size

Target

Accrual to date

Final

743

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

GSK Investigational Site - Darlinghurst, Sydney

Recruitment hospital [2]

GSK Investigational Site - Darlinghurst

Recruitment hospital [3]

GSK Investigational Site - Surry Hills

Recruitment hospital [4]

GSK Investigational Site - Sydney

Recruitment hospital [5]

GSK Investigational Site - Fortitude Valley

Recruitment hospital [6]

GSK Investigational Site - Carlton

Recruitment hospital [7]

GSK Investigational Site - Clayton

Recruitment hospital [8]

GSK Investigational Site - North Fitzroy

Recruitment hospital [9]

GSK Investigational Site - Prahran

Recruitment postcode(s) [1]

2010 - Darlinghurst, Sydney

Recruitment postcode(s) [2]

2010 - Darlinghurst

Recruitment postcode(s) [3]

2010 - Surry Hills

Recruitment postcode(s) [4]

2010 - Sydney

Recruitment postcode(s) [5]

4006 - Fortitude Valley

Recruitment postcode(s) [6]

3053 - Carlton

Recruitment postcode(s) [7]

3168 - Clayton

Recruitment postcode(s) [8]

3078 - North Fitzroy

Recruitment postcode(s) [9]

3181 - Prahran

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

District of Columbia

Country [4]

United States of America

State/province [4]

Florida

Country [5]

United States of America

State/province [5]

Georgia

Country [6]

United States of America

State/province [6]

Illinois

Country [7]

United States of America

State/province [7]

Indiana

Country [8]

United States of America

State/province [8]

Massachusetts

Country [9]

United States of America

State/province [9]

Michigan

Country [10]

United States of America

State/province [10]

Minnesota

Country [11]

United States of America

State/province [11]

Missouri

Country [12]

United States of America

State/province [12]

Nevada

Country [13]

United States of America

State/province [13]

New Jersey

Country [14]

United States of America

State/province [14]

New York

Country [15]

United States of America

State/province [15]

North Carolina

Country [16]

United States of America

State/province [16]

Pennsylvania

Country [17]

United States of America

State/province [17]

Tennessee

Country [18]

United States of America

State/province [18]

Texas

Country [19]

United States of America

State/province [19]

Virginia

Country [20]

Belgium

State/province [20]

Antwerpen

Country [21]

Belgium

State/province [21]

Brussels

Country [22]

Belgium

State/province [22]

Brussel

Country [23]

Belgium

State/province [23]

Gent

Country [24]

Canada

State/province [24]

Manitoba

Country [25]

Canada

State/province [25]

Ontario

Country [26]

Canada

State/province [26]

Quebec

Country [27]

France

State/province [27]

Bordeaux

Country [28]

France

State/province [28]

Marseille

Country [29]

France

State/province [29]

Nice

Country [30]

France

State/province [30]

Paris Cedex 13

Country [31]

France

State/province [31]

Paris

Country [32]

France

State/province [32]

Tourcoing cedex

Country [33]

Germany

State/province [33]

Bayern

Country [34]

Germany

State/province [34]

Hessen

Country [35]

Germany

State/province [35]

Niedersachsen

Country [36]

Germany

State/province [36]

Nordrhein-Westfalen

Country [37]

Germany

State/province [37]

Berlin

Country [38]

Germany

State/province [38]

Hamburg

Country [39]

Germany

State/province [39]

München

Country [40]

Japan

State/province [40]

Aichi

Country [41]

Japan

State/province [41]

Chiba

Country [42]

Japan

State/province [42]

Tokyo

Country [43]

Netherlands

State/province [43]

Rotterdam

Country [44]

Spain

State/province [44]

Galicia

Country [45]

Spain

State/province [45]

Alcala de Henares

Country [46]

Spain

State/province [46]

Alicante

Country [47]

Spain

State/province [47]

Badalona

Country [48]

Spain

State/province [48]

Barcelona

Country [49]

Spain

State/province [49]

Cartagena (Murcia)

Country [50]

Spain

State/province [50]

Elche

Country [51]

Spain

State/province [51]

Granada

Country [52]

Spain

State/province [52]

Granollers (Barcelona)

Country [53]

Spain

State/province [53]

Huelva

Country [54]

Spain

State/province [54]

L'Hospitalet de Llobregat

Country [55]

Spain

State/province [55]

Madrid

Country [56]

Spain

State/province [56]

Majadahonda (Madrid)

Country [57]

Spain

State/province [57]

Marbella

Country [58]

Spain

State/province [58]

Mataró

Country [59]

Spain

State/province [59]

Murcia

Country [60]

Spain

State/province [60]

Málaga

Country [61]

Spain

State/province [61]

Santiago de Compostela

Country [62]

Spain

State/province [62]

Sevilla

Country [63]

Spain

State/province [63]

Valencia

Country [64]

Spain

State/province [64]

Vilajoyosa

Country [65]

Spain

State/province [65]

Zaragoza

Country [66]

United Kingdom

State/province [66]

West Midlands

Country [67]

United Kingdom

State/province [67]

Birmingham

Country [68]

United Kingdom

State/province [68]

Brighton

Country [69]

United Kingdom

State/province [69]

Bristol

Country [70]

United Kingdom

State/province [70]

Crumpsall, Manchester

Country [71]

United Kingdom

State/province [71]

Liverpool

Country [72]

United Kingdom

State/province [72]

London

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

ViiV Healthcare

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

GlaxoSmithKline

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT03446573

Trial related presentations / publications

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.
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.

Public notes

Contacts

Principal investigator

Name

GSK Clinical Trials

Address

ViiV Healthcare

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03446573

Trial Review

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03446573