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Integrase Strand Transfer Inhibitor

DOR/ISL for HIV

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 baseline (day 1) and week 144
Awards & highlights
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 144
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and week 144 for reporting.

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 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 study objectives
Change from baseline in CD4+ T-cells at Week 144
Change from baseline in CD4+ T-cells at Week 96
Change from baseline in body weight at Week 144
+11 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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 144 weeks.
Group II: BIC/FTC/TAFActive Control2 Interventions
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DOR/ISL
2020
Completed Phase 3
~750

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,216 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,989 Total Patients Enrolled

Media Library

BIC (Integrase Strand Transfer Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05705349 — Phase 3
HIV Research Study Groups: DOR/ISL, BIC/FTC/TAF
HIV Clinical Trial 2023: BIC Highlights & Side Effects. Trial Name: NCT05705349 — Phase 3
BIC (Integrase Strand Transfer Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705349 — Phase 3
HIV Patient Testimony for trial: Trial Name: NCT05705349 — Phase 3
~145 spots leftby Oct 2025
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