Phase 3
Completed N=493
Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)
HIV Infections
Source: ClinicalTrials.gov NCT04021290 ↗
Enrolled (actual)
493
Serious AEs
4.1%
Results posted
Jul 2022
Primary outcomePrimary: 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 — 1; 3 Participants
◆ Published Evidence
Highly cited
166citations · ~55 / year
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.
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 (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.
Linked Publications (5)
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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.
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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.
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Patient-Reported Outcomes After Switching to a 2-Drug Regimen of Fixed-Dose Combination Dolutegravir/Lamivudine: 48-Week Results from the SALSA Study.
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Two-drug HIV regimens: more data still needed.
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Dolutegravir/Lamivudine Efficacy and Safety Outcomes in People With HIV-1 With or Without Historical Resistance Results at Screening: 48-Week Pooled Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1; 3 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 48 |
232; 229 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA >=50 c/mL as Per FDA Snapshot Category at Week 24 |
0; 1 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 24 |
234; 237 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Week 24 |
30.5; 10 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count for Week 48 |
30; 2 | — |
| SECONDARY Change From Baseline in CD4+/ Cluster of Differentiation 8 (CD8+) Cell Counts Ratio for Week 24 |
-0.02; 0.01 | — |
| SECONDARY Change From Baseline in CD4+/CD8+ Cell Counts Ratio for Week 48 |
0.04; 0.05 | — |
| SECONDARY Number of Participants With Disease Progression Through Week 24 |
0; 0 | — |
| SECONDARY Number of Participants With Disease Progression Through Week 48 |
1; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and AEs Leading to Discontinuation |
180; 172; 5; 3 | — |
| SECONDARY Number of Participants With AEs by Severity Grades |
92; 67; 77; 86; 10; 17 | — |
| SECONDARY Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
1; 3; 1; 1; 0; 2 | — |
| SECONDARY 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 |
179; 169; 91; 66; 77; 84 | — |
| SECONDARY Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 |
0; 1 | — |
| SECONDARY Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 |
5; 2 | — |
| SECONDARY Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Fasting Lipids at Week 24 |
-4.944; -3.571; -0.326; 0.585; -3.096; 0.058 | — |
| SECONDARY Change From Baseline in Fasting Lipids at Week 48 |
-3.112; -4.002; -0.809; 0.688; 0.131; 2.668 | — |
| SECONDARY Number of Participants With Observed Genotypic and Phenotypic Resistance to Antiretrovirals (ARVs) for Participants Meeting Confirmed Virologic Withdrawal (CVW) Criteria |
— | — |
| SECONDARY Change From Baseline in Health Status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24 |
2.9; 1 | <0.001 sig |
| SECONDARY Change From Baseline in Health Status by HIV TSQ at Week 48 |
2.9; 1 | <0.001 sig |
| SECONDARY Change From Baseline in Health Status by Symptom Distress Module (SDM) at Week 24 |
-2.6; -0.7 | 0.021 sig |
| SECONDARY Change From Baseline in Health Status by SDM at Week 48 |
-2.4; -1.5 | 0.398 |
| SECONDARY Change From Baseline in Health Status by SDM in Continuation Phase |
-4.1; -3.4; -6.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 = 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 200 c/mL.
- Participants within the 12 month window prior to Screening and after confirmed suppression to =50 c/mL. A single plasma HIV-1 RNA measurement >50 c/mL but less than 200 c/mL, with confirmation of return to =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.
Data sourced from ClinicalTrials.gov (NCT04021290) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.