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Antiretroviral

DOR/ISL Switch for HIV

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
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 at day 1 and week 96
Awards & highlights

Study Summary

This trial will compare the effectiveness & safety of 2 HIV drug regimens to see which works best for 48 weeks.

Who is the study for?
This trial is for adults with HIV-1 who are virologically suppressed on BIC/FTC/TAF therapy. Participants must have maintained viral suppression for at least 3 months and cannot be pregnant, breastfeeding, or planning to become pregnant. They should not have a history of treatment failure or resistance to DOR, active hepatitis B or C infections, certain cancers within the last 5 years, or be using strong immune system affecting drugs.Check my eligibility
What is being tested?
The study compares switching HIV-1 positive patients from their current medication (BIC/FTC/TAF) to a new combination drug (DOR/ISL) versus continuing their current regimen. The goal is to see if DOR/ISL maintains virus suppression as effectively as BIC/FTC/TAF after 48 weeks without causing significant side effects.See study design
What are the potential side effects?
Potential side effects include those commonly associated with antiretroviral therapy such as nausea, headache, fatigue, and diarrhea. Specific side effects related to DOR/ISL may also occur but are being studied for comparison against the established treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline at day 1 and week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline at day 1 and week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants who discontinue study intervention due to AEs through Week 48
Percentage of participants who experience adverse events (AEs) through Week 48
Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48
Secondary outcome measures
Change from baseline in CD4+ T-cell count at Week 48
Change from baseline in CD4+ T-cell count at Week 96
Number of participants with viral drug resistance mutations at Week 48
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DOR/ISL and Placebo to BIC/FTC/TAFExperimental Treatment2 Interventions
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 96.
Group II: BIC/FTC/TAF and Placebo to DOR/ISLActive Control2 Interventions
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 96.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DOR/ISL
2020
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,070 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,979 Total Patients Enrolled

Media Library

BIC/FTC/TAF (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT05630755 — Phase 3
HIV Research Study Groups: DOR/ISL and Placebo to BIC/FTC/TAF, BIC/FTC/TAF and Placebo to DOR/ISL
HIV Clinical Trial 2023: BIC/FTC/TAF Highlights & Side Effects. Trial Name: NCT05630755 — Phase 3
BIC/FTC/TAF (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630755 — Phase 3

Frequently Asked Questions

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

Has this treatment been given the green light from the FDA?

"Our team at Power has given this treatment an assessment of 3, as Phase 3 trials have generated evidence in favour of its efficacy as well as multiple rounds that demonstrate safety."

Answered by AI

Are there currently any opportunities for individuals to sign up for this research?

"According to the info listed on clinicaltrials.gov, this experiment is in its recruitment phase and was initially posted on February 17th 2023 before being amended June 7th of that same year."

Answered by AI

What is the upper limit on participant numbers for this clinical evaluation?

"Merck Sharp & Dohme LLC are the study sponsors and they have determined that 501 participants who meet the inclusion criteria must be recruited. To this end, Mercer University's Department of Internal Medicine in Macon, Georgia and Prism Health North Texas' Oak Cliff Health Center in Dallas New South Wales will both host clinical trial sites."

Answered by AI

To what end does this investigation seek to achieve?

"Merck Sharp & Dohme LLC, the trial's sponsor, has reported that its primary outcome for evaluation is the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48. Other secondary objectives include assessing mean change from baseline in CD4+ T-cell count at Week 96 and ascertaining the quantity of patients who abandon treatment due to adverse events (AEs) over the duration of this study; additionally, they will also assess Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48."

Answered by AI

Are any Canadian facilities sponsoring this clinical trial?

"33 participating medical centers are enrolled in this trial, such as Mercer University's Department of Internal Medicine (Site 1411) located in Macon, Prism Health North Texas and Oak Cliff Health Center ( Site 1409) based out of Dallas, as well as Holdsworth House Medical Practice ( Site 6200 ) situated in Darlinghurst."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
AHF The Kinder Medical Group ( Site 1426)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
2023. "A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630755.
All > Hiv
~150 spots leftby Nov 2024
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