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

NCT03446573 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2048622015-004401-17
• Study Type: interventional
• Target: 743
• Locations: 10 countries
• Sites: 133

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.

Conditions

HIV Infections

Keywords

Switch study; Non-inferiority; Human immunodeficiency virus type 1; Tenofovir alafenamide; Dolutegravir; Lamivudine

Outcome Measures

Primary Outcomes (1)

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

  Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.

  Week 48

Secondary Outcomes (64)

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

  Week 48

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

  Week 24

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

  Weeks 96 and 144

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

  Week 24

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

  Weeks 96 and 144

Study Arms (2)

DTG + 3TC 50 mg/300 mg

EXPERIMENTAL

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).

Drug: DTG + 3TC

TAF based regimen (TBR)

ACTIVE COMPARATOR

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).

Drug: TAF based regimen (TBR)

Interventions

DTG + 3TC DRUG

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.

DTG + 3TC 50 mg/300 mg

TAF based regimen (TBR) DRUG

Participants will continue to receive their TBR.

TAF based regimen (TBR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (133)

GSK Investigational Site

Phoenix, Arizona, 85012, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85260, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90036, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Oakland, California, 94602, United States

Location

GSK Investigational Site

Rialto, California, 92337, United States

Location

GSK Investigational Site

Sacramento, California, 95825, United States

Location

GSK Investigational Site

San Leandro, California, 94577, United States

Location

GSK Investigational Site

Torrance, California, 90502, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20005, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32209, United States

Location

GSK Investigational Site

Miami, Florida, 33133, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Miami Beach, Florida, 33140, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

Sarasota, Florida, 34237, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33407, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Macon, Georgia, 31201, United States

Location

GSK Investigational Site

Savannah, Georgia, 31401, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01105, United States

Location

GSK Investigational Site

Berkley, Michigan, 48072, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55407, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55415, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63139, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89106, United States

Location

GSK Investigational Site

Newark, New Jersey, 07102, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38105-3678, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Bellaire, Texas, 77401, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

El Paso, Texas, 79935, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Houston, Texas, 77098, United States

Location

GSK Investigational Site

Lynchburg, Virginia, 24501, United States

Location

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Darlinghurst, Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Surry Hills, New South Wales, 2010, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Fortitude Valley, Queensland, 4006, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Fitzroy North, Victoria, 3078, Australia

Location

GSK Investigational Site

Prahran, Victoria, 3181, Australia

Location

GSK Investigational Site

Antwerp, 2000, Belgium

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Brussels, 1090, Belgium

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4E9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3A 1T1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Bordeaux, 33000, France

Location

GSK Investigational Site

Marseille, 13003, France

Location

GSK Investigational Site

Nice, 06202, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Tourcoing, 59208, France

Location

GSK Investigational Site

Munich, Bavaria, 80335, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80336, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81675, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50668, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50674, Germany

Location

GSK Investigational Site

Berlin, 10439, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Hamburg, 20146, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

München, 80336, Germany

Location

GSK Investigational Site

Aichi, 460-0001, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Tokyo, 108-8639, Japan

Location

GSK Investigational Site

Tokyo, 173-8606, Japan

Location

GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

Location

GSK Investigational Site

Vigo, Galicia, 36204, Spain

Location

GSK Investigational Site

Alcalá de Henares, 28805, Spain

Location

GSK Investigational Site

Alicante, 03010, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Cartagena (Murcia), 30202, Spain

Location

GSK Investigational Site

Elche, 03203, Spain

Location

GSK Investigational Site

Granada, 18014, Spain

Location

GSK Investigational Site

Granollers (Barcelona), 08400, Spain

Location

GSK Investigational Site

Huelva, 21080, Spain

Location

GSK Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Majadahonda (Madrid), 28222, Spain

Location

GSK Investigational Site

Marbella, 29603, Spain

Location

GSK Investigational Site

Mataró, 08304, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Murcia, 30003, Spain

Location

GSK Investigational Site

Murcia, 30008, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Seville, 41041, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Vilajoyosa, 3570, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

GSK Investigational Site

Birmingham, West Midlands, B4 6TH, United Kingdom

Location

GSK Investigational Site

Birmingham, WS2 9PS, United Kingdom

Location

GSK Investigational Site

Brighton, BN2 1ES, United Kingdom

Location

GSK Investigational Site

Bristol, BS10 5NB, United Kingdom

Location

GSK Investigational Site

Crumpsall, Manchester, M8 5RB, United Kingdom

Location

GSK Investigational Site

Liverpool, L7 8XP, United Kingdom

Location

GSK Investigational Site

London, WC1E 6LB, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 31905383 BACKGROUND

• Scholten S, Cahn P, Portilla J, Bisshop F, Hodder S, Ruane P, Kaplan R, Wynne BR, Man CY, Grove R, Wang R, Jones B, Ait-Khaled M, Kisare M, Okoli C. Dolutegravir/Lamivudine Efficacy and Safety Outcomes in People With HIV-1 With or Without Historical Resistance Results at Screening: 48-Week Pooled Analysis. Open Forum Infect Dis. 2024 Jul 1;11(7):ofae365. doi: 10.1093/ofid/ofae365. eCollection 2024 Jul.

  PMID: 39015350 DERIVED

• Ait-Khaled M, Oyee J, Ooi AYR, Wynne B, Maldonado A, Jones B, Wang T. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based Regimen in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1: Subgroup Analysis of Participants With Elvitegravir as Baseline Third Agent From the TANGO Study. Open Forum Infect Dis. 2024 May 2;11(5):ofae227. doi: 10.1093/ofid/ofae227. eCollection 2024 May.

  PMID: 38737429 DERIVED

• Chandasana H, Singh R, Adkison K, Ait-Khaled M, Pene Dumitrescu T. Population pharmacokinetic modeling of dolutegravir/lamivudine to support a once-daily fixed-dose combination regimen in virologically suppressed adults living with HIV-1. Antimicrob Agents Chemother. 2024 May 2;68(5):e0150423. doi: 10.1128/aac.01504-23. Epub 2024 Apr 8.

  PMID: 38587380 DERIVED

• Walmsley S, Smith DE, Gorgolas M, Cahn PE, Lutz T, Lacombe K, Kumar PN, Wynne B, Grove R, Bontempo G, Moodley R, Okoli C, Kisare M, Jones B, Clark A, Ait-Khaled M. Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged >/= 50 years: week 48 pooled results from the TANGO and SALSA studies. AIDS Res Ther. 2024 Mar 21;21(1):17. doi: 10.1186/s12981-024-00604-9.

  PMID: 38515183 DERIVED

• Wang R, Underwood M, Llibre JM, Bernal Morell E, Brinson C, Sanz Moreno J, Scholten S, Moore R, Saggu P, Oyee J, Moodley R, Wynne B, Kisare M, Jones B, Ait-Khaled M. Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables: Three-Year Results of the Randomized TANGO Study. Open Forum Infect Dis. 2023 Dec 9;11(1):ofad626. doi: 10.1093/ofid/ofad626. eCollection 2024 Jan.

  PMID: 38213637 DERIVED

• Batterham RL, Espinosa N, Katlama C, McKellar M, Scholten S, Smith DE, Ait-Khaled M, George N, Wright J, Gordon LA, Moodley R, Wynne B, van Wyk J. Cardiometabolic Parameters 3 Years After Switch to Dolutegravir/Lamivudine vs Maintenance of Tenofovir Alafenamide-Based Regimens. Open Forum Infect Dis. 2023 Jul 12;10(7):ofad359. doi: 10.1093/ofid/ofad359. eCollection 2023 Jul.

  PMID: 37520420 DERIVED

• Wang R, Wright J, Saggu P, Ait-Khaled M, Moodley R, Parry CM, Lutz T, Podzamczer D, Moore R, Gorgolas Hernandez-Mora M, Kinder C, Wynne B, van Wyk J, Underwood M. Assessing the Virologic Impact of Archived Resistance in the Dolutegravir/Lamivudine 2-Drug Regimen HIV-1 Switch Study TANGO through Week 144. Viruses. 2023 Jun 11;15(6):1350. doi: 10.3390/v15061350.

  PMID: 37376649 DERIVED

• Osiyemi O, De Wit S, Ajana F, Bisshop F, Portilla J, Routy JP, Wyen C, Ait-Khaled M, Leone P, Pappa KA, Wang R, Wright J, George N, Wynne B, Aboud M, van Wyk J, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial. Clin Infect Dis. 2022 Sep 29;75(6):975-986. doi: 10.1093/cid/ciac036.

  PMID: 35079789 DERIVED

• 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.

  PMID: 33587500 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This will be an open-label study and therefore no blinding is required. No summaries of the study data according to actual randomized treatment groups will be available to sponsor staff prior to the planned Week 24 preliminary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 \[NNRTI\]).

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 27, 2018
• Study Start: January 18, 2018
• Primary Completion: May 20, 2019
• Study Completion: May 3, 2022
• Last Updated: July 19, 2023
• Results First Posted: June 2, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AU (9); FR (7); CA (5); JP (4); NL (1); BE (5); ES (29); US (54); DE (12); GB (7)