DTG/3TC for HIV
(EYEWITNESS 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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants switch to DTG/3TC FDC and are monitored for virologic suppression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DTG/3TC FDC
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViiV Healthcare
Lead Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration