206 Participants Needed

DTG/3TC for HIV

(EYEWITNESS Trial)

Recruiting at 60 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: ViiV Healthcare
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

Will I have to stop taking my current medications?

The trial requires participants to switch from their current HIV medication (BIC/FTC/TAF) to the study medication (DTG/3TC). If you are currently on BIC/FTC/TAF, you will need to stop taking it to participate in the trial.

What data supports the effectiveness of the drug DTG/3TC for HIV treatment?

Research shows that the drug combination of dolutegravir (DTG) and lamivudine (3TC) is effective and well-tolerated for treating HIV, both in patients who are new to treatment and those who have been treated before. It is considered a good alternative to more complex drug regimens, with similar effectiveness and fewer side effects.12345

Is DTG/3TC safe for humans?

Studies show that the combination of dolutegravir (DTG) and lamivudine (3TC) is generally safe for people with HIV, with only mild side effects like indigestion and fatigue reported. No serious complications or treatment discontinuations were observed in the studies.56789

What makes the drug DTG/3TC unique for treating HIV?

DTG/3TC is a unique HIV treatment because it combines two drugs, dolutegravir and lamivudine, into a single tablet, making it simpler and potentially more convenient than traditional three-drug regimens. It is effective for both treatment-naive patients and those switching from other therapies, offering a streamlined option with fewer drugs.4681011

Eligibility Criteria

This trial is for people over 50 living with HIV who have been on ART for at least a year and BIC/FTC/TAF for six months without interruption. They must have maintained viral suppression, with no virologic failure history or severe liver disease, hepatitis B infection, untreated syphilis, significant allergies to study drugs, major drug resistance mutations in HIV-1, or any life-threatening conditions.

Inclusion Criteria

Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may be eligible upon discussion and agreement with the medical monitor
Participants living with HIV-1 with documented plasma HIV-1 RNA <50 c/mL within 3 months prior to Screening
I have been on HIV medication for over a year without major breaks.
See 3 more

Exclusion Criteria

I haven't shown severe COVID-19 symptoms in the last 14 days.
I have tested positive for hepatitis B.
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to DTG/3TC FDC and are monitored for virologic suppression

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Treatment Details

Interventions

  • DTG/3TC FDC
Trial Overview The trial tests if switching from the current HIV treatment (BIC/FTC/TAF) to a new combination pill (DTG/3TC) maintains virus control after 48 weeks. Participants will be monitored to ensure their HIV remains suppressed following the switch.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants Receiving DTG/3TC FDCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

References

48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort. [2023]
Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens. [2023]
Real-world implementation of dolutegravir plus lamivudine in people living with HIV in Southwest China. [2022]
Long-term data on the efficacy and tolerability of lamivudine plus dolutegravir as a switch strategy in a multi-centre cohort of HIV-1-infected, virologically suppressed patients. [2020]
Dolutegravir plus lamivudine for the treatment of HIV-1 infection. [2021]
Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults. [2022]
Dolutegravir plus lamivudine versus efavirenz plus tenofovir disoproxil fumarate and lamivudine in antiretroviral-naive adults with HIV-1 infection. [2022]
Doing More With Less: Review of Dolutegravir-Lamivudine, a Novel Single-Tablet Regimen for Antiretroviral-Naïve Adults With HIV-1 Infection. [2020]
Real-World Effectiveness, Tolerability, and Safety of Dolutegravir/Lamivudine in Korea. [2023]
Three-year efficacy of switching to dolutegravir plus lamivudine: A real-world study. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. [2021]