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Antiretroviral Therapy
DTG/3TC for HIV (EYEWITNESS Trial)
Phase 3
Recruiting
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 baseline (day 1) and at weeks 24,48, and 96
Awards & highlights
EYEWITNESS 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.Check my eligibility
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.See study design
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.
EYEWITNESS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and at weeks 24,48, and 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at weeks 24,48, and 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (≥)50 Copies/Millilitre (c/mL) per Snapshot Algorithm at Week 48
Secondary outcome measures
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at 24, 48 and 96 Weeks
Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at 24, 48 and 96 Weeks
Change From Baseline in CD4+ Cells Count at 24, 48 and 96 Weeks
+6 moreEYEWITNESS Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants Receiving DTG/3TC FDCExperimental Treatment1 Intervention
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Who is running the clinical trial?
ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
468,379 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't shown severe COVID-19 symptoms in the last 14 days.I have tested positive for hepatitis B.I have been on HIV medication for over a year without major breaks.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.My liver function is severely impaired.I have been taking BIC/FTC/TAF continuously for at least 6 months.I may have a serious infection but not skin Kaposi's sarcoma needing systemic treatment.I have never changed my HIV treatment due to it not working.I don't have liver disease, untreated syphilis, allergies to the study treatment, ongoing cancer other than exceptions, significant suicide risk, major drug resistance mutations, severe lab test abnormalities, or specific liver or kidney issues.
Research Study Groups:
This trial has the following groups:- Group 1: Participants Receiving DTG/3TC FDC
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process still open for this clinical trial?
"As reported on clinicaltrials.gov, this trial is actively searching for participants. It was originally posted to the site as of July 7th 2023 and underwent its most recent update just 10 days later, on July 17th."
Answered by AI
What are the potential hazards associated with DTG/3TC FDC for patients?
"The safety of DTG/3TC FDC has been assessed at 3, indicating that sufficient clinical evidence exists to support its efficacy and toxicity."
Answered by AI
How many participants are currently signed up for this clinical trial?
"Affirmative. The information available on clinicaltrials.gov confirms that the recruitment process for this medical trial is ongoing, which was first posted on July 7th 2023 and updated recently in 17th of the same month. This study requires 200 participants from a single research centre to be enrolled."
Answered by AI
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