AzTrials
AzTrials

HIV InfectionsPhase 3NCT04021290

Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

A Phase 3 study testing DTG/3TC FDC and CAR in people with HIV Infections, run by ViiV Healthcare at 119 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
DTG/3TC FDC and CAR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
119 sitesin 17 countries
Study dates
11 Nov 2019to 9 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions; participant must be likely to complete the study as planned; participants should be considered appropriate candidates for participation in an investigative clinical trial with oral medication (example given [e.g.] no active problematic substance abuse, acute major organ disease, or potential long-term work assignments out of the country).
  • Participant should be aged 18 years or older (or older, if required by local regulatory agencies), at the time of signing the informed consent.
  • Participants living with HIV.
  • 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.
  • Participant must be on uninterrupted current regimen (either the initial or second Combination antiretroviral therapy [cART] regimen) for at least 3 months prior to Screening.
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  • Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification and must not have been done for suspected or established treatment failure. The following switches, if they are the only switches, would not be considered a change in regimen. a) A switch from a PI boosted with ritonavir (RTV) to the same PI boosted with cobicistat is allowed (and vice versa). b) A switch from 3TC to emtricitabine (FTC) (and vice versa). c) A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) (and vice versa).
  • Acceptable stable cART regimens prior to Screening include 2 NRTIs plus a) INI (either the initial or second cART regimen) b) NNRTI (either the initial or second cART regimen) c) Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen).
  • A male or female participant.
  • 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 breastfeeding, and at least one of the following conditions applies; not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period from 28 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication. All participants 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; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Participant must be capable of giving signed informed consent.
  • Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Who cannot join

  • Women who are pregnant or 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 per cubic millimeter (mm^3) are not exclusionary.
  • Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
  • Participants with unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Participants with the 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. Participant's positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti-HBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and not anti-HBc Immunoglobulin M (IgM). Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a TAF/TDF regimen are excluded.
  • Participants with anticipated need for any hepatitis C virus (HCV) therapy during the randomized phase of the study, or anticipated need for HCV therapy with a potential for adverse drug-drug interactions with DTG or 3TC.
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  • Participants with 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.
  • Participants with history or presence of allergy intolerance to the study interventions or their components or drugs of their class.
  • Participants with 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.
  • Participants with any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication.
  • Use of any regimen consisting of single or dual ART (peri-partum treatment with single dose nevirapine is allowed).
  • Participants with current use of stavudine, didanosine, or nelfinavir.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Participants receiving treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Participants receiving treatment with any of the following agents within 28 days of Screening like radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant.
  • Participants with 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).
  • Any evidence of major NRTI mutation or presence of any DTG resistance-associated mutation in any available prior resistance genotype assay test result, if known.
  • Participants with any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.
  • Participants with alanine aminotransferase (ALT) >= 5 times the upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent direct bilirubin).
  • Participants with creatinine clearance of <30 mL/min/1.73m^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method. Participants with creatinine clearance between 30 to 49 mL/min/1.73 m^2 are eligible after the medical monitor has provided approval after reviewing participant's current ART regimen.
  • Participants with any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant'sparticipation in the study of an investigational compound.
  • Participants within the 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.
  • Participants within the 12 month window prior to Screening and after confirmed suppression to <50 c/mL, 2 or more consecutive plasma HIV-1 RNA measurements >=50 c/mL. A single plasma HIV-1 RNA measurement >50 c/mL but less than 200 c/mL, with confirmation of return to <50 c/mL is allowed.
  • 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 with 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.
  • Participants who are currently participating in or anticipate to be selected for any other interventional study after randomization.
  • 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.

Trial locations and contacts

119 sites in 17 countries.

119 sites in 17 countries

United States16 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Morgantown, West Virginia, 26506

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    San Francisco, California, 94110

  • GSK Investigational Site

    Savannah, Georgia, 31401

  • GSK Investigational Site

    St Louis, Missouri, 63108

  • GSK Investigational Site

    Tulsa, Oklahoma, 74127

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

Spain15 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Badalona, Barcelona, 8916

  • GSK Investigational Site

    Cadiz, 11009

  • GSK Investigational Site

    Granada, 18016

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Palma de Mallorca, 07198

  • GSK Investigational Site

    San Sebastián de los Reyes, 28702

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38010

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

United Kingdom11 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Brighton, BN2 1ES

  • GSK Investigational Site

    Bristol, BS10 5NB

  • GSK Investigational Site

    Leeds, Yorkshire, LS9 7TF

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    London, SW10 9TH

  • GSK Investigational Site

    London, WC1E 6LB

  • GSK Investigational Site

    Manchester, M13 0FH

  • GSK Investigational Site

    Manchester, M8 5RB

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Sheffield, S10 2JF

Other trials in United Kingdom

Germany10 sites

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53105

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50668

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50674

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Hamburg, 20146

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    München, Bavaria, 81675

  • GSK Investigational Site

    München, 80336

  • GSK Investigational Site

    Munich, Bavaria, 80335

Other trials in Germany

Italy9 sites

  • GSK Investigational Site

    Bergamo, 24128

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Milan, Lombardy, 20157

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41100

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Rome, Lazio, 00149

  • GSK Investigational Site

    Rome, Lazio, 00168

Other trials in Italy

France8 sites

  • GSK Investigational Site

    Bobigny, 93000

  • GSK Investigational Site

    Bordeaux, 33075

  • GSK Investigational Site

    Nice, 6202

  • GSK Investigational Site

    Orléans, 45067

  • GSK Investigational Site

    Paris, 75010

  • GSK Investigational Site

    Paris, 75012

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tourcoing, 59208

Other trials in France

Brazil7 sites

  • GSK Investigational Site

    Campinas, São Paulo, 13015-080

  • GSK Investigational Site

    Curitiba, Paraná, 80060-900

  • GSK Investigational Site

    Manaus, 69040-000

  • GSK Investigational Site

    Rio de Janeiro, 21040-360

  • GSK Investigational Site

    Salvador, Estado de Bahia, 40110-060

  • GSK Investigational Site

    São Paulo, 01246-090

  • GSK Investigational Site

    São Paulo, 04039-032

Other trials in Brazil

Canada7 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4E9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2T1

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Taiwan6 sites

  • GSK Investigational Site

    Kaohsiumg, 81362

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    New Taipei City, 220

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 10016

  • GSK Investigational Site

    Taoyuan, 330

Other trials in Taiwan

China5 sites

  • GSK Investigational Site

    Beijing, 100015

  • GSK Investigational Site

    Beijing, 100069

  • GSK Investigational Site

    Chongqing, 400000

  • GSK Investigational Site

    Guangzhou, Guangdong, 510060

  • GSK Investigational Site

    Shanghai, 201508

Other trials in China

Argentina4 sites

  • GSK Investigational Site

    Buenos Aires, 1405

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AWK

  • GSK Investigational Site

    Ciudad de Buenos Aires, Buenos Aires, C1202ABB

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000PBJ

Other trials in Argentina

Denmark4 sites

  • GSK Investigational Site

    Aarhus, 8200

  • GSK Investigational Site

    Copenhagen, DK-2100

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Mexico4 sites

  • GSK Investigational Site

    Distrito Federal, 06470

  • GSK Investigational Site

    Guadalajara, Jalisco, 44160

  • GSK Investigational Site

    Guadalajara, Jalisco, 44280

  • GSK Investigational Site

    Zapopan, Jalisco, 45170

Other trials in Mexico

Sweden4 sites

  • GSK Investigational Site

    Gothenburg, SE-416 85

  • GSK Investigational Site

    Malmö, SE-205 02

  • GSK Investigational Site

    Stockholm, SE-118 83

  • GSK Investigational Site

    Stockholm, SE-14186

Other trials in Sweden

Belgium3 sites

  • GSK Investigational Site

    Antwerp, 2000

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Ghent, 9000

Other trials in Belgium

Russia3 sites

  • GSK Investigational Site

    Saint Petersburg, 196645

  • GSK Investigational Site

    Tolyatti, 445846

  • GSK Investigational Site

    Yekaterinburg, 620149

Other trials in Russia

South Africa3 sites

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7505

  • GSK Investigational Site

    Observatory, Cape Town, 7925

Other trials in South Africa

About this study

Official title: A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.

Conditions
HIV Infections
Being tested
DTG/3TC FDC, CAR
Keywords
Current antiretroviral regimen (CAR), HIV-1, Long-term antiviral activity, Dolutegravir/lamivudine, Fixed dose combination
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTG/3TC FDCDrug

    DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route.

  • CARDrug

    Participants who are randomized to the CAR arm will continue to take the current treatment until Week 52. CAR will include 2 NTRIs plus either an INI, NNRTI, or boosted PI or atazanavir unboosted.

Study groups in NCT04021290
Study groupRoleWhat they receive
Participants receiving DTG/3TC FDCExperimentalEligible participants will be randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from Day 1 up to 52 weeks. Participants who complete 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
Receives: Drug: DTG/3TC FDC
Participants receiving CARActive comparatorEligible participants will continue to receive CAR from Day 1 up to 52 weeks.
Receives: Drug: CAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48

    Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: Week 48

Secondary outcomes (26)

  1. Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 48

    Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: Week 48

  2. Number of Participants With Plasma HIV-1 RNA >=50 c/mL as Per FDA Snapshot Category at Week 24

    Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: Week 24

  3. Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 24

    Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

    Measured: Week 24

  4. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Week 24

    CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

    Measured: Baseline (Day 1) and Week 24

  5. Change From Baseline in CD4+ Cell Count for Week 48

    CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

    Measured: Baseline (Day 1) and Week 48

  6. Change From Baseline in CD4+/ Cluster of Differentiation 8 (CD8+) Cell Counts Ratio for Week 24

    CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

    Measured: Baseline (Day 1) and Week 24

  7. Change From Baseline in CD4+/CD8+ Cell Counts Ratio for Week 48

    CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

    Measured: Baseline (Day 1) and Week 48

  8. Number of Participants With Disease Progression Through Week 24

    Participants with disease progression included incidences of HIV-associated conditions, Acquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

    Measured: Up to Week 24

  9. Number of Participants With Disease Progression Through Week 48

    Participants with disease progression included incidences of HIV-associated conditions, AIDS and death. HIV-associated conditions were assessed according to the 2014 HIV infection by CDC classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

    Measured: Up to Week 48

  10. Number of Participants With Adverse Events (AEs) and AEs Leading to Discontinuation

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: Up to Week 52

  11. Number of Participants With AEs by Severity Grades

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms

    Measured: Up to 52 weeks

  12. Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks

    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN.

    Measured: Up to Week 52

  13. Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.

    Measured: Up to 52 weeks

  14. Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.

    Measured: Up to 52 weeks

  15. Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: Up to 52 weeks

  16. Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: Up to 52 weeks

  17. Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN.

    Measured: Up to Week 52

  18. Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN.

    Measured: Up to Week 52

  19. Change From Baseline in Fasting Lipids at Week 24

    Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.

    Measured: Baseline (Day 1) and Week 24

  20. Change From Baseline in Fasting Lipids at Week 48

    Lipid parameters included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.

    Measured: Baseline (Day 1) and Week 48

  21. Number of Participants With Observed Genotypic and Phenotypic Resistance to Antiretrovirals (ARVs) for Participants Meeting Confirmed Virologic Withdrawal (CVW) Criteria

    Genotypic and phenotypic testing was conducted for participants who met the CVW criteria, i.e., one assessment with HIV-1 RNA ≥200 c/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 c/mL at any point in the study.

    Measured: Up to week 48

  22. Change From Baseline in Health Status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24

    The HIV Treatment Satisfaction Questionnaire (HIVTSQ) is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

    Measured: Baseline (Day 1) and Week 24

  23. Change From Baseline in Health Status by HIV TSQ at Week 48

    The HIVTSQ is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

    Measured: Baseline (Day 1) and Week 48

  24. Change From Baseline in Health Status by Symptom Distress Module (SDM) at Week 24

    SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health).

    Measured: Baseline (Day 1) and Week 24

  25. Change From Baseline in Health Status by SDM at Week 48

    SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health).

    Measured: Baseline (Day 1) and Week 48

  26. Change From Baseline in Health Status by SDM in Continuation Phase

    SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health).

    Measured: Baseline (Day 1) and Week 76, Week 100, and Week 132

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start11 Nov 2019
  3. Primary completion23 Apr 2021
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 FDC will receive DTG/3TC FDC up to Week 52. Participants randomized to CAR will continue to take their current regimen up to Week 52. Randomization will be stratified by Baseline third agent class (protease inhibitor \[PI\], integrase inhibitor \[INI\], or non-nucleoside reverse transcriptase inhibitor \[NNRTI\]).
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021290
Sponsor's protocol ID
208090
Status last verified
Oct 2023
First submitted
11 Jul 2019
Last updated
19 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023 Feb 18;76(4):720-729. doi: 10.1093/cid/ciac130.

    PubMed 35235656

  • Kumar P, Clarke AE, Jonsson-Oldenbuttel C, Deltoro MG, Di Giambenedetto S, Brites C, Hocqueloux L, Lu PL, Oyee J, Oglesby A, Wynne B, Jones B, Evitt LA, Fox D, Kisare M, Priest J. Patient-Reported Outcomes After Switching to a 2-Drug Regimen of Fixed-Dose Combination Dolutegravir/Lamivudine: 48-Week Results from the SALSA Study. AIDS Behav. 2025 Jan;29(1):235-245. doi: 10.1007/s10461-024-04479-9. Epub 2024 Sep 3.

    PubMed 39225890

  • 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.

    PubMed 39015350

  • 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.

    PubMed 38515183

  • Masters MC, Cohn SE. Two-drug HIV regimens: more data still needed. Lancet HIV. 2021 Aug;8(8):e454-e455. doi: 10.1016/S2352-3018(21)00106-5. No abstract available.

    PubMed 34358493

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTG/3TC FDC and CAR in people with HIV Infections, run by ViiV Healthcare at 119 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Spain, United Kingdom, Germany, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021290, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

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