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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
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to check if the combination of DOR and ISL is safe and well-tolerated in adults with HIV-1 who have used these drugs before. The study focuses on ensuring that the treatment does not cause harmful side effects in these patients.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with One or More Adverse Event (AE)
Percentage of participants who Discontinue Study Intervention Due to an AE
Secondary study objectives
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
+1 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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DOR/ISL
2020
Completed Phase 3
~750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV/AIDS include non-nucleoside reverse transcriptase inhibitors (NNRTIs) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs). NNRTIs, such as Doravirine, inhibit the reverse transcriptase enzyme by binding to a specific site, preventing the enzyme from converting viral RNA into DNA, which is essential for HIV replication.
NRTTIs, like Islatravir, also target the reverse transcriptase enzyme but work by incorporating themselves into the viral DNA, causing premature termination of the DNA chain. These mechanisms are crucial for HIV/AIDS patients as they significantly reduce the viral load, improve immune function, and decrease the risk of HIV-related complications, thereby enhancing the quality of life and prolonging survival.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,150 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,819 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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