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Integrase Inhibitor

Dolutegravir / Lamivudine Pill for HIV (DYAD Trial)

Phase 4

Waitlist Available

Research Sponsored by Charlotte-Paige Rolle, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4, 12, 24 and 48 weeks (or at study withdrawal)

Awards & highlights

DYAD Trial Summary

This trial will test if it is safe to switch people with HIV who are taking bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine and if it is just as effective.

DYAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4, 12, 24 and 48 weeks (or at study withdrawal)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4, 12, 24 and 48 weeks (or at study withdrawal)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 12, 24 and 48 weeks (or at study withdrawal) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The measure is to evaluate the efficacy of switching from B/F/TAF to DTG/3TC versus continuing B/F/TAF as determined by the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48

Secondary outcome measures

The measure is to assess health related quality of life for subjects treated with DTG/3TC compared to B/F/TAF over time using the HIV-Symptoms Index questionnaire

The measure is to evaluate changes in BMI (kg/m2) in those treated with DTG/3TC vs. B/F/TAF over time

The measure is to evaluate changes in waist circumference (inches) in those treated with DTG/3TC vs. B/F/TAF over time

+8 more

DYAD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment group 1Experimental Treatment1 Intervention

Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.

Group II: Treatment group 2Active Control1 Intervention

Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lamivudine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Charlotte-Paige Rolle, MDLead Sponsor

ViiV HealthcareIndustry Sponsor

360 Previous Clinical Trials

468,357 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research currently recruiting participants?

"Unfortunately, this research is no longer recruiting individuals. It was initially posted on September 22nd 2020 and underwent its most recent update two years later. However, there are 107 clinical trials for human immunodeficiency virus type 1 (HIV-1) infection currently enrolling patients and 134 studies seeking participants to trial Dolutegravir/Lamivudine Pill combination therapy."

Answered by AI

How does the safety profile of Dolutegravir / Lamivudine Pill compare to other medications?

"After careful evaluation, the safety of Dolutegravir / Lamivudine Pill was determined to be a 3 due to its Phase 4 trial status, which signifies that this medication has been formally endorsed."

Answered by AI

What maladies are regularly treated with Dolutegravir / Lamivudine Pill?

"The Dolutegravir/Lamivudine Pill is primarily used to combat anti-retroviral agents, yet it may also be prescribed for patients who have not been previously treated with medication, do not possess any resistance to darunavir, and are afflicted by human immunodeficiency virus type 1 (HIV-1)."

Answered by AI

What is the aggregate amount of people enrolled in this experiment?

"At this moment, recruitment for the trial is not open. The study was first posted on September 22nd 2020 and was modified most recently in September 2022. If you are searching for similar studies, there are presently 107 trials recruiting patients with human immunodeficiency virus type 1 (HIV-1) infection and 134 research projects that seek participants to take a Dolutegravir / Lamivudine Pill combination."

Answered by AI

Are there any other trials that have explored the efficacy of a Dolutegravir / Lamivudine Pill?

"Currently, 134 clinical trials investigating Dolutegravir / Lamivudine Pill are being conducted. Of which 37 have progressed to Phase 3. All these tests were initiated from Shanghai, but now span a total of 1,891 sites across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Charlotte-Paige Rolle, MD 2020. "Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585737.