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Antiretroviral Therapy

DOR/ISL for HIV/AIDS

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

Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.

Be older than 18 years old

Must not have

Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma.

Has HIV-2 infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 144

Awards & highlights

Pivotal Trial

Summary

This trial will compare the safety and efficacy of switching to a new drug regimen (MK-8591A) versus continuing the current drug regimen (BIC/FTC/TAF) in HIV-1 infected individuals who are currently virally suppressed. The primary hypothesis is that the new drug regimen will be at least as effective as the current drug regimen in maintaining viral suppression.

Who is the study for?

This trial is for HIV-1 positive adults with a stable viral load under 50 copies/mL on BIC/FTC/TAF therapy for at least 3 months, without past treatment failure. Women must not be pregnant or breastfeeding and either not of childbearing potential or using contraception. Exclusions include recent participation in other studies, resistance to DOR, intent to conceive, HIV-2 infection, active hepatitis or certain cancers within the last 5 years.

What is being tested?

The study tests if switching from BIC/FTC/TAF to a new drug combo (Doravirine/Islatravir) maintains low HIV levels. Participants are randomly assigned to continue their current meds or switch to the new one. The main goal is seeing if the new combo works just as well by checking virus levels after 48 weeks.

What are the potential side effects?

Potential side effects aren't specified here but typically may include gastrointestinal issues like nausea and diarrhea, headaches, fatigue, and possible allergic reactions among others commonly seen with antiretroviral drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been on BIC/FTC/TAF for HIV with successful results for over 3 months and never failed any HIV treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer in the last 5 years, except for certain skin cancers or in situ cervical cancer.

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I am infected with HIV-2.

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I have an active hepatitis diagnosis.

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I am not on, nor do I need, any drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 144

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 144

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48

Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48

Percentage of Participants With One or More Adverse Events (AEs) up to Week 48

Secondary study objectives

Change From Baseline in Body Weight at Week 144

Change From Baseline in Body Weight at Week 48

Change From Baseline in Body Weight at Week 96

+14 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

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

A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.

Group II: BIC/FTC/TAFActive Control3 Interventions

50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOR/ISL

2020

Completed Phase 3

~750

0 / 5Eligibility criteria met