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Antiretroviral

DOR/ISL for HIV/AIDS

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
Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) 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.
Is HIV-1 positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 48-96 (up to ~48 weeks)
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug combination in people with HIV who have the virus under control with current treatment. The new combination includes doravirine and islatravir. The goal is to see if the new treatment is at least as good as the current one in controlling the virus.

Who is the study for?
This trial is for adults with HIV-1 who are not pregnant or breastfeeding, have been on a stable ART regimen with suppressed viral load for at least 3 months, and have no history of treatment failure. Women must use contraception or be non-childbearing. Exclusions include HIV-2 infection, hypersensitivity to study drugs, active hepatitis or malignancy within the past 5 years.Check my eligibility
What is being tested?
The trial tests if switching to MK-8591A (doravirine/islatravir) is as effective as continuing current ART in maintaining low HIV RNA levels (<50 copies/mL). Participants will either continue their current therapy or switch to the new combination drug and results will be compared after 48 weeks.See study design
What are the potential side effects?
Potential side effects may include but are not limited to allergic reactions to medication components, liver problems like hepatitis flare-ups if previously infected, and other common drug-related adverse events such as fatigue, headache, gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a stable HIV treatment for over 3 months without past treatment failures.
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I am HIV-1 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 48-96 (up to ~48 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 48-96 (up to ~48 weeks) 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 Discontinued Study Intervention up to Week 48
15S RNA
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 48 for InSTI-based Regimens (Non-PI-containing Regimens)
Lipids
Lipids
+16 more

Side effects data

From 2023 Phase 3 trial • 35 Patients • NCT04233216
29%
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: Doravirine/Islatravir (DOR/ISL)Experimental Treatment1 Intervention
Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.
Group II: Baseline Background Antiretroviral Therapy (ART)Active Control2 Interventions
Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.
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
4,581,611 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,302 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,192 Total Patients Enrolled

Media Library

DOR/ISL (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04223778 — Phase 3
HIV/AIDS Clinical Trial 2023: DOR/ISL Highlights & Side Effects. Trial Name: NCT04223778 — Phase 3
DOR/ISL (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223778 — Phase 3
HIV/AIDS Research Study Groups: Doravirine/Islatravir (DOR/ISL), Baseline Background Antiretroviral Therapy (ART)

Frequently Asked Questions

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

How many distinct venues is this experiment taking place in?

"This clinical trial is running at Toronto General Hospital - University Health Network (Site 1105) in Orlando, Florida and Bliss Healthcare Services ( Site 1025) located in Washington D.C., with an additional 20 other sites including Georgetown University Hospital (Site 1018) situated in Hillsborough, New jersey."

Answered by AI

What are the major goals of this research project?

"Merck Sharp & Dohme Corp. states that the main outcome of this study, which will be measured over a 48-week period, is Percentage of Participants With One or More Adverse Events (AEs). Additionally, there are secondary outcomes being assessed such as Percentage Change From Week 48 in CD4+ T-cell Count at Week 96 and Percentage Change From Baseline in CD4+ T-cell Count at Week 96. Lastly, researchers are also noting the variance between baseline readings to week 48 for Fasting Lipids amongst participants on InSTI-based Regimens (Non-PI Containing regimens) who have"

Answered by AI

Are any enrollees being accepted into this research endeavor currently?

"Per the information posted on clinicaltrials.gov, this clinical trial is not currently enlisting participants. The study was first created on February 18th 2020 and its status last updated November 3rd 2022. Notwithstading that no further recruitment is taking place, 634 other medical trials are actively seeking patients at present."

Answered by AI

Are there any known adverse effects resulting from the administration of Doravirine/Islatravir (DOR/ISL)?

"There is prior clinical evidence that supports the safety of Doravirine/Islatravir (DOR/ISL), so it was rated as a 3 on our team's risk assessment scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
2020. "Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04223778.
~130 spots leftby Apr 2025
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