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NCT03945981 · ClinicalTrials.gov registry record · Phase 3
Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
A Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 16
- Study locations
NCT03945981: Completed Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
NCT03945981 is a Phase 3 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 131 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower). The trial reports 16 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945981, a Phase 3 study of HIV Infections, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 16
- Study locations
Study Summary
Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are willing to start study treatment immediately following diagnosis will receive 50 milligram (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and 4 weeks of follow up period if required. This study will be conducted in United States (US) with approximately 120 participants.
Primary Outcome
Participants were classified as "HIV-1 RNA \<50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA \< 50 c/mL' if the last viral load within the Week 24 visit window was \<50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination \[FDC\] to another ART was not penalized) and as HIV-1 RNA \>= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit w
Conditions Studied
Interventions
- DRUG Dolutegravir + Lamivudine FDC
Study Locations (16)
Florida
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Miami
- GSK Investigational Site - Oakland Park
- GSK Investigational Site - Orlando
- GSK Investigational Site - Orlando
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Bellaire
- GSK Investigational Site - Dallas
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
Georgia
- GSK Investigational Site - Decatur
- GSK Investigational Site - Savannah
Alabama
- GSK Investigational Site - Birmingham
Minnesota
- GSK Investigational Site - Minneapolis
Missouri
- GSK Investigational Site - St Louis
North Carolina
- GSK Investigational Site - Huntersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2020-10-20 |
| Phase | Phase 3 |
What the finished NCT03945981 record still lists
NCT03945981 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Dolutegravir + Lamivudine FDC is the first listed.
NCT03945981 lists 16 locations in 8 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT03945981 about?
NCT03945981 is a clinical study titled "Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults". Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of different...
What is the current status of trial NCT03945981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2019-07-02. Estimated completion is 2020-10-20.
What conditions does trial NCT03945981 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT03945981?
The interventions under investigation include: Dolutegravir + Lamivudine FDC (DRUG).
Who is sponsoring clinical trial NCT03945981?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03945981 being conducted?
This trial has 16 study locations across Alabama, California, Florida, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03945981's enrollment target sits among peer trials
131 226th of 542 higher than 317 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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