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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 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
+16 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%
Hypertension
7%
Intermittent claudication
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: 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
~80
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,684 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,375 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,265 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical indications for DOR/ISL?
"DOR/ISL is an effective treatment for hepatitis b, chronic, antiretroviral treatment naive, and virologically suppressed (hiv-1 rna less than 50 copies per ml)."
Answered by AI
How many test subjects are currently signed up for this experiment?
"This study is no longer enrolling patients. The trial was initially posted on February 28th, 2020 and last updated on November 1st, 2020. For individuals seeking other studies, 879 trials involving human immunodeficiency virus type 1 (hiv-1) are actively recruiting and 118 studies for DOR/ISL are also looking for participants."
Answered by AI
Are Canadian doctors also conducting this research?
"There are presently 19 sites where this clinical trial is recruiting patients from. To minimize travel requirements, it is important to select the site closest you. The sites are located in Orlando, Columbus and Phoenix as well as 16 other locations."
Answered by AI
Are there other examples of DOR/ISL being researched?
"DOR/ISL was first studied in 2002 at University of Zurich. In the 18 years since, there have been 368 completed clinical trials. Currently, there are 118 trials underway with many of them based in Orlando, Florida."
Answered by AI
How does the safety profile of DOR/ISL compare to other similar treatments?
"DOR/ISL is believed to be a safe medication, as it has received a 3 on Power's safety scale. This is due to the fact that Phase 3 trials have both efficacy and safety data available."
Answered by AI
Who else is applying?
What site did they apply to?
Clinique Medicale L Actuel ( Site 5714)
What portion of applicants met pre-screening criteria?
Met criteria
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