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Antiretroviral
DOR/ISL for HIV
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
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 week 144
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new once-daily pill for HIV-1 infection. The pill contains two drugs, doravirine and islatravir. The trial will compare the new pill to a currently available pill that contains three drugs, bictegravir, emtricitabine, and tenofovir alafenamide. The trial will last 48 weeks and the primary outcome will be the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48.
Who is the study for?
This trial is for adults who have recently been diagnosed with HIV-1 and haven't started treatment yet. They should not be pregnant or breastfeeding, must use reliable contraception if they can bear children, and cannot have a history of certain cancers or other conditions that might affect the study results.
What is being tested?
The study tests a once-daily pill combining two drugs (Doravirine/Islatravir) against an established HIV treatment (Bictegravir/Emtricitabine/Tenofovir). Participants are randomly assigned to one of these treatments in a blinded manner to compare effectiveness and safety at reducing the virus levels after 48 weeks.
What are the potential side effects?
Potential side effects may include but are not limited to nausea, headache, fatigue, diarrhea, skin reactions, and changes in liver enzymes. The exact side effects will be monitored throughout the trial as each individual's reaction can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and week 144
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 144
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Secondary study objectives
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
+16 moreSide effects data
From 2024 Phase 3 trial • 672 Patients • NCT0422377810%
Headache
7%
Accidental overdose
5%
COVID-19
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doravirine/Islatravir (DOR/ISL)
Baseline Background Antiretroviral Therapy (ART)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: DOR/ISLExperimental Treatment2 Interventions
Treatment-naïve participants with HIV-1 receive blinded DOR/ISL and placebo to BIC/FTC/TAF once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label DOR/ISL up to Week 168.
Group II: Group 2: BIC/FTC/TAFActive Control2 Interventions
Treatment-naïve participants with HIV-1 receive blinded BIC/FTC/TAF and placebo to DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label BIC/FTC/TAF up to Week 168.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DOR/ISL
2020
Completed Phase 3
~750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,623 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,184,644 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,885 Previous Clinical Trials
8,088,186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.I am not on, nor will I need, any immune-weakening drugs during the study.I am a woman and do not plan to get pregnant or donate eggs during the study.I am not pregnant or breastfeeding, and I either cannot become pregnant, am using contraception, or am not having sex.I have taken HIV medication for 10 days or less after being diagnosed.I have an active hepatitis diagnosis, including hepatitis B.My HIV treatment has failed due to drug resistance.I am infected with HIV-2.I've been treated for a virus other than HIV with medication that also works against HIV.I am HIV-1 positive.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: BIC/FTC/TAF
- Group 2: Group 1: 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.
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