DOR/ISL for HIV

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

Eligibility Criteria

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.

Inclusion Criteria

Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening

I have been on a stable HIV treatment for over 3 months with no past treatment failures.

I am not able to have children, or I use birth control or do not have penile-vaginal sex, and I have a negative pregnancy test.

Exclusion Criteria

I am infected with HIV-2.

I have an active hepatitis B infection.

I have taken long-acting HIV therapy before.

+7 more

Participant Groups

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.

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).

ART is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Antiretroviral Therapy for: