DTG/3TC for HIV

(EYEWITNESS Trial)

Not currently recruiting at 75 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ViiV Healthcare

Must be taking: Antiretrovirals

Disqualifiers: Pregnancy, Hepatitis B, Liver disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new HIV treatment, DTG/3TC FDC (a fixed-dose combination of two drugs), to determine if it can control the virus as effectively as current medication. The focus is on individuals with HIV-1 who have successfully managed their condition with their current medication for over a year. Participants should have maintained an HIV viral load below a certain level and followed a specific medication regimen for at least six months. The trial aims to see if switching to the new treatment can sustain these results. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the dolutegravir/lamivudine (DTG/3TC) combination pill is generally safe and easy to manage. One study found this combination effective in maintaining low virus levels in the body, crucial for people with HIV. Another study reported good results over 48 weeks, with no major safety issues. These findings suggest that the treatment is well-tolerated, with few side effects. Long-term use of DTG/3TC indicates it is a reliable option for people living with HIV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Researchers are excited about DTG/3TC FDC for HIV because it combines two active ingredients, dolutegravir (DTG) and lamivudine (3TC), into a single pill. Unlike traditional treatments that often involve multiple pills or combinations such as DTG with tenofovir and emtricitabine, this fixed-dose combination simplifies the treatment regimen, making it easier for patients to adhere to their medication schedule. Additionally, DTG/3TC has shown potential for strong efficacy with a lower risk of side effects, which is promising for improving the quality of life for those living with HIV.

What evidence suggests that DTG/3TC FDC might be an effective treatment for HIV?

Research has shown that the combination of dolutegravir and lamivudine (DTG/3TC) effectively treats HIV-1. One study found that 64% to 95% of individuals with very high viral loads had their virus controlled by week 48. Another study demonstrated that almost all participants achieved viral suppression by week 48, proving its strong effectiveness. Participants who switched to DTG/3TC reported greater satisfaction compared to their previous treatment. These findings suggest that DTG/3TC can effectively control the virus in many patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Participants Receiving DTG/3TC FDC Experimental Treatment 1 Intervention

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

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12366928/

Dolutegravir + lamivudine effectiveness and tolerability in ...

Among people initiating DTG + 3TC with very high (≥500,000 copies/mL) baseline viral loads, 64% to 95% achieved virologic suppression at week 48 ...

2.

academic.oup.com

academic.oup.com/ofid/article/12/3/ofaf135/8059175

Efficacy and Safety Outcomes in Adults Initiating Dolutegravir ...

In the single-arm STAT study, DTG/3TC fixed-dose combination demonstrated high efficacy and a good safety profile as a first-line regimen for adults naive ...

3.

eatg.org

eatg.org/hiv-news/first-line-art-regimen-dtg-3tc-efficacious-in-adults-with-high-hiv-viral-load/

First-line ART regimen DTG/3TC efficacious in adults with ...

Nearly all patients who received DTG/3TC in the single-arm STAT study achieved virologic suppression at week 48, with the exception of 3 ...

4.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT02384395

Study Details | NCT02384395 | Safety and Efficacy of Fixed ...

The investigators propose to evaluate the efficacy and time to viral suppression with DTG/3TC/ABC FDC as initial therapy for acute HIV infection (AHI), as well ...

5.

link.springer.com

link.springer.com/article/10.1007/s10461-024-04479-9

Patient-Reported Outcomes After Switching to a 2-Drug ...

Participants who switched to DTG/3TC reported rapid and sustained improvements in treatment satisfaction compared with those who continued CAR.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40532657/

Long-term efficacy and safety of fixed-dose dolutegravir ...

ConclusionThe study demonstrates that the DTG/3TC FDC is an effective, safe, and well-tolerated regimen for maintaining virological suppression ...

7.

thelancet.com

thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00373-1/fulltext

Once-daily dolutegravir/lamivudine fixed-dose formulations ...

This study assessed the pharmacokinetics and 48-week safety outcomes of once-daily DTG/3TC, using a dispersible tablet (DT) fixed-dose combination (5/30 mg) or ...