DTG/3TC for HIV (EYEWITNESS Trial)

Phase 3

Waitlist Available

Research Sponsored by ViiV Healthcare

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 up to week 96

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial evaluates if HIV-1 patients over 50 can switch treatments & stay virus-free for 48 weeks.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of DTG/3TC may include headache, diarrhea, nausea, fatigue and rare but serious risks like allergic reactions or liver problems. The exact side effects will be closely monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of Participants With Treatment Related Non-serious Adverse Events, all Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation