Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)
Public ClinicalTrials.gov record NCT04021290. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04021290
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 493 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 11, 2019 (Actual)
- Primary completion
- Apr 23, 2021 (Actual)
- Completion
- Sep 9, 2022 (Actual)
- Last update posted
- Oct 19, 2023
2019 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | San Francisco | California | 94110 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20017 | — |
| GSK Investigational Site | Pensacola | Florida | 32503 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Savannah | Georgia | 31401 | — |
| GSK Investigational Site | Kansas City | Kansas | 66160 | — |
| GSK Investigational Site | St Louis | Missouri | 63108 | — |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74127 | — |
| GSK Investigational Site | Morgantown | West Virginia | 26506 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04021290, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04021290 live on ClinicalTrials.gov.