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COMPLETED Phase 3

Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults

NCT03945981 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 131 participants
Start Date 2019-07-02
Est. Completion 2020-10-20
Phase Phase 3

Sponsor

ViiV Healthcare

82 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03945981 reports 16 study locations spanning 8 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03945981?

The interventions under investigation include: Dolutegravir + Lamivudine FDC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03945981?

This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial