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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 week 48 up to week 144

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will evaluate the safety and effectiveness of a new HIV treatment compared with the current one.

Who is the study for?

This trial is for adults with HIV-1 who are successfully managing their virus levels (below 50 copies/mL) on current ART regimens without any history of treatment failure. Women must either not be able to bear children or use reliable contraception and have a negative pregnancy test.

What is being tested?

The study compares the safety and effectiveness of switching to Doravirine/Islatravir (DOR/ISL) versus continuing with existing ART at keeping HIV-1 RNA below detectable levels after 48 weeks, aiming to prove DOR/ISL is just as good.

What are the potential side effects?

While specific side effects aren't listed here, common ones for antiretroviral drugs include nausea, headaches, tiredness, and potential liver issues. The trial will monitor participants closely for any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48 up to week 144

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48 up to week 144

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 up to 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

Participants with HIV-1 RNA ≥50 copies/mL at Week 48

Participants with an AE leading to discontinuation of study intervention at Week 48

Participants with one or more AEs at Week 48

Secondary study objectives

Change from Day 1 in CD4+ T-cell count at Week 144

Change from Day 1 in CD4+ T-cell count at Week 96

Change from Day 1 in cluster of differentiation 4+ (CD4+) T-cell count at Week 48

+21 more

Side effects data

From 2024 Phase 3 trial • 672 Patients • NCT04223778

10%

Headache

Accidental overdose

COVID-19

Osteoarthritis

100%

80%

60%

40%

20%

Study treatment Arm

Doravirine/Islatravir (DOR/ISL)

Baseline Background Antiretroviral Therapy (ART)

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DOR/ISLExperimental Treatment1 Intervention

Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are treated with DOR/ISL for 144 weeks. Participants will have the option to continue in an optional study extension and receive DOR/ISL for up to an additional 96 weeks or until DOR/ISL is commercially accessible (whichever comes first).

Group II: ART + DOR/ISLActive Control2 Interventions

Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are first treated with standard of care (SOC) ART for 48 weeks, followed by 96 weeks of treatment with DOR/ISL Participants will have the option to continue in an optional study extension and receive DOR/ISL for up to an additional 96 weeks or until DOR/ISL is 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

Do I qualify?Apply below to find out