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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 102 weeks
Awards & highlights
Study Summary
This trial will investigate the safety and effectiveness of a drug in HIV-1 patients who have previously used it. No hypotheses are tested.
Who is the study for?
This trial is for adults with HIV-1 who were previously treated with DOR/ISL in certain Merck Sharp & Dohme clinical studies. It's not open to those who are heavily treatment-experienced from other trials.Check my eligibility
What is being tested?
The study is testing the safety and how well people tolerate a combination HIV drug called Doravirine/Islatravir (DOR/ISL). There's no specific hypothesis being tested; it's more about ongoing observation of participants' reactions to the drug.See study design
What are the potential side effects?
While the trial aims to assess safety, potential side effects aren't specified here. Generally, HIV medications can cause issues like nausea, headache, fatigue, and sometimes more serious effects depending on individual health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 102 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 102 weeks
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 with One or More Adverse Event (AE)
Percentage of participants who Discontinue Study Intervention Due to an AE
Secondary outcome measures
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96
+1 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%
Intermittent claudication
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
C-reactive protein increased
7%
Motor dysfunction
7%
Oropharyngeal pain
7%
Haematuria
7%
Proteinuria
7%
Sleep terror
7%
Hypertension
7%
Arthralgia
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
1Treatment groups
Experimental Treatment
Group I: DOR/ISLExperimental Treatment1 Intervention
Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken 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
3,906 Previous Clinical Trials
5,064,168 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,788 Previous Clinical Trials
8,065,402 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My HIV-1 RNA level is 200 copies/mL or higher.I am currently in a clinical study for DOR/ISL by MSD.
Research Study Groups:
This trial has the following groups:- Group 1: DOR/ISL
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
HIV/AIDS Patient Testimony for trial: Trial Name: NCT05766501 — Phase 3
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