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Integrase Strand Transfer Inhibitor
DOR/ISL for HIV
Phase 3
Recruiting
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 baseline (day 1) and week 96
Awards & highlights
Summary
This trial tests the safety, effectiveness and tolerance of a new HIV-1 treatment for people who haven't had any treatment before.
Who is the study for?
This trial is for adults with HIV-1 who haven't had any antiretroviral therapy. Women must not be pregnant, breastfeeding, or if capable of childbearing, agree to use contraception. Participants need a viral load over 500 copies/mL but can't join if they have HIV-2, recent AIDS-related infections, active hepatitis B or C with cirrhosis signs, certain cancers within the last 5 years, or conditions that might skew results.Check my eligibility
What is being tested?
The study compares two HIV treatments: DOR/ISL and BIC/FTC/TAF. It's randomized and double-blind meaning participants are put into groups by chance without knowing which treatment they get. The goal is to see if DOR/ISL works as well as BIC/FTC/TAF in reducing the virus to undetectable levels after 48 weeks.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue; gastrointestinal issues like nausea; potential liver problems signaled by yellowing skin or eyes; and changes in body fat distribution.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 96
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 discontinuing from study treatment due to an AE through Week 48
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Secondary outcome measures
Change from baseline in CD4+ T-cells at Week 96
Change from baseline in body weight at Week 48
Change from baseline in body weight at Week 96
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DOR/ISLExperimental Treatment2 Interventions
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 96 weeks.
Group II: BIC/FTC/TAFActive Control2 Interventions
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 96 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 LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,763 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,830 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a serious infection related to AIDS within the last month.I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.I am infected with HIV-2.I have an active hepatitis B infection.I have chronic hepatitis C with signs of cirrhosis.I am not pregnant, breastfeeding, and willing to use birth control or abstain from sex if I can have children.I have never taken HIV medication since my diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: DOR/ISL
- Group 2: BIC/FTC/TAF
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.
HIV Patient Testimony for trial: Trial Name: NCT05705349 — Phase 3
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