599 Participants Needed

DOR/ISL for HIV

Recruiting at 94 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults who have recently been diagnosed with HIV-1 and haven't started treatment yet. They should not be pregnant or breastfeeding, must use reliable contraception if they can bear children, and cannot have a history of certain cancers or other conditions that might affect the study results.

Inclusion Criteria

I am not pregnant or breastfeeding, and I either cannot become pregnant, am using contraception, or am not having sex.
I have taken HIV medication for 10 days or less after being diagnosed.
I am HIV-1 positive.

Exclusion Criteria

Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.
I am not on, nor will I need, any immune-weakening drugs during the study.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blinded DOR/ISL or BIC/FTC/TAF from Day 1 to Week 96

96 weeks

Open-label extension

Participants receive open-label DOR/ISL or BIC/FTC/TAF up to Week 144

48 weeks

Long-term follow-up

Participants who benefit from treatment may continue their assigned intervention up to Week 168

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
  • Doravirine/Islatravir (DOR/ISL)
Trial Overview The study tests a once-daily pill combining two drugs (Doravirine/Islatravir) against an established HIV treatment (Bictegravir/Emtricitabine/Tenofovir). Participants are randomly assigned to one of these treatments in a blinded manner to compare effectiveness and safety at reducing the virus levels after 48 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: DOR/ISLExperimental Treatment2 Interventions
Treatment-naïve participants with HIV-1 receive blinded DOR/ISL and placebo to BIC/FTC/TAF once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label DOR/ISL up to Week 168.
Group II: Group 2: BIC/FTC/TAFActive Control2 Interventions
Treatment-naïve participants with HIV-1 receive blinded BIC/FTC/TAF and placebo to DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label BIC/FTC/TAF up to Week 168.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

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