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Antiretroviral Therapy
DOR/ISL for HIV/AIDS
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
Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 144
Awards & highlights
Study Summary
This trial will compare the safety and efficacy of switching to a new drug regimen (MK-8591A) versus continuing the current drug regimen (BIC/FTC/TAF) in HIV-1 infected individuals who are currently virally suppressed. The primary hypothesis is that the new drug regimen will be at least as effective as the current drug regimen in maintaining viral suppression.
Who is the study for?
This trial is for HIV-1 positive adults with a stable viral load under 50 copies/mL on BIC/FTC/TAF therapy for at least 3 months, without past treatment failure. Women must not be pregnant or breastfeeding and either not of childbearing potential or using contraception. Exclusions include recent participation in other studies, resistance to DOR, intent to conceive, HIV-2 infection, active hepatitis or certain cancers within the last 5 years.Check my eligibility
What is being tested?
The study tests if switching from BIC/FTC/TAF to a new drug combo (Doravirine/Islatravir) maintains low HIV levels. Participants are randomly assigned to continue their current meds or switch to the new one. The main goal is seeing if the new combo works just as well by checking virus levels after 48 weeks.See study design
What are the potential side effects?
Potential side effects aren't specified here but typically may include gastrointestinal issues like nausea and diarrhea, headaches, fatigue, and possible allergic reactions among others commonly seen with antiretroviral drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on BIC/FTC/TAF for HIV with successful results for over 3 months and never failed any HIV treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 144
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 144
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
Secondary outcome measures
Change From Baseline in Body Weight at Week 144
Change From Baseline in Body Weight at Week 48
Change From Baseline in Body Weight at Week 96
+14 moreSide effects data
From 2023 Phase 3 trial • 35 Patients • NCT0423321629%
Diarrhoea
21%
Lymphocyte count decreased
21%
COVID-19
21%
Creatinine renal clearance decreased
14%
Headache
14%
Fatigue
14%
Nausea
14%
Accidental overdose
14%
Rash
7%
Oropharyngeal pain
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
C-reactive protein increased
7%
Arthralgia
7%
Motor dysfunction
7%
Intermittent claudication
7%
Hypertension
7%
Proteinuria
7%
Sleep terror
7%
Haematuria
7%
Postoperative wound infection
7%
Urinary tract infection
7%
Pancytopenia
7%
Memory impairment
7%
Dry eye
7%
Intestinal transit time increased
7%
Eye irritation
7%
Skin candida
7%
Upper respiratory tract infection
7%
Obesity
7%
Anaemia
7%
Chest pain
7%
Exposure to communicable disease
7%
Abdominal pain
7%
Mitral valve incompetence
7%
Pyrexia
7%
Blood creatine phosphokinase increased
7%
Amoebiasis
7%
Blood calcium increased
7%
Anaemia postoperative
7%
Blood cholesterol increased
7%
Respiratory tract infection viral
7%
Device dislocation
7%
Blood glucose increased
7%
Myelopathy
7%
Cough
7%
Night sweats
7%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DOR+ART
DOR/ISL+ART
Placebo+ART
ISL+ART
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DOR/ISLExperimental Treatment2 Interventions
A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.
Group II: BIC/FTC/TAFActive Control3 Interventions
50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.
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
5,053,910 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,185 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,843 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on BIC/FTC/TAF for HIV with successful results for over 3 months and never failed any HIV treatments.I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.I am not pregnant or breastfeeding, and I either cannot become pregnant, am using birth control, or am not having sex.I am infected with HIV-2.I have an active hepatitis diagnosis.I am not on, nor do I need, any drugs that weaken my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: BIC/FTC/TAF
- Group 2: DOR/ISL
Awards:
This trial has 1 awards, including:- 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.
Has DOR/ISL received official sanctioning from the FDA?
"DOR/ISL's safety is estimated to be a 3."
Answered by AI
How many medical facilities are administering this clinical trial?
"Patients can go to Pacific Oaks Medical Group (Site 2765) in Beverly Hills, California; Kaiser Permanente Los Angeles Medical Center (Site 2775) in Los Angeles, District of Columbia; or Eisenhower Medical Center (Site 2744) in Palm Springs, Florida for this study. There are also 32 other locations that are participating."
Answered by AI
Why was this clinical trial designed in this way?
"The sponsor of the clinical trial, Merck Sharp & Dohme Corp., has announced that the primary outcome measure for this study will be Participants with one or more adverse events (AEs) up to Week 48. Additionally, secondary outcomes including Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96 and Change From Baseline in Body Weight at Weeks 96 and 144 will also be measured."
Answered by AI
Are we still receiving applications for this research project?
"This particular trial, as reflected on clinicaltrials.gov, is not currently looking for new participants. It was first posted on February 18th 2020 and last updated November 1st 2020. There are 654 other trials that patients could consider enrolling in at this time."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
Men's Health Foundation ( Site 2749)
North Texas ID Consultants, PA ( Site 2707)
What portion of applicants met pre-screening criteria?
Met criteria
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