Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03945981
The ClinicalTrials.gov registry entry for NCT03945981 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
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 reports 16 study locations spanning 8 distinct geographic areas - top geographies include 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
Similar trials for HIV Infections
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.
-
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
RECRUITING · Phase 3
-
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
RECRUITING · Phase 3
-
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
RECRUITING · Phase 3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
ACTIVE NOT RECRUITING · Phase 3
-
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.