DOR/ISL Switch for HIV

Recruiting at 48 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: BIC/FTC/TAF

Must not be taking: Immunosuppressants, CYP3A inducers

Disqualifiers: HIV-2, Active AIDS, HBV, HCV, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 144 weeks

514 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if switching to a new HIV treatment is as good or better than continuing the current treatment. The study focuses on people with HIV-1 who are already on a specific treatment. The new treatment works by reducing the amount of HIV in the blood, helping to keep the immune system healthy.

Do I need to stop my current medications for the trial?

Yes, you will need to stop your current HIV medication (BIC/FTC/TAF) to switch to the new study medication (DOR/ISL) as part of the trial.

What data supports the effectiveness of the drug DOR/ISL Switch for HIV?

Research shows that switching to the drug combination BIC/FTC/TAF is effective in maintaining viral suppression in people living with HIV, even in those who have experienced previous treatment failures. This suggests that similar drug combinations, like DOR/ISL, may also be effective in managing HIV. ^{1 2 3 4 5}

What makes the DOR/ISL drug unique for treating HIV?

The DOR/ISL drug is unique because it combines two nucleoside reverse transcriptase inhibitors (NRTIs) with opposing resistance profiles, which means they can potentially overcome resistance seen in other treatments. This combination could be effective for patients with different HIV-1 subtypes, including those who have failed other therapies. ^{3 4 6 7 8}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with HIV-1 who are virologically suppressed on BIC/FTC/TAF therapy. Participants must have maintained viral suppression for at least 3 months and cannot be pregnant, breastfeeding, or planning to become pregnant. They should not have a history of treatment failure or resistance to DOR, active hepatitis B or C infections, certain cancers within the last 5 years, or be using strong immune system affecting drugs.

Inclusion Criteria

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

I am not able to have children, or if I can, I am not pregnant or breastfeeding and agree to use birth control or abstain from sex during the study.

I have been on BIC/FTC/TAF for HIV with successful control for over 3 months.

Exclusion Criteria

I am on or might need drugs that strongly affect my immune system.

I have an active hepatitis B infection.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DOR/ISL or BIC/FTC/TAF once daily from day 1 to week 144

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

96 weeks

Open-label extension (optional)

Eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible

Up to 96 weeks

Treatment Details

Interventions

• BIC/FTC/TAF
• DOR/ISL

Trial Overview The study compares switching HIV-1 positive patients from their current medication (BIC/FTC/TAF) to a new combination drug (DOR/ISL) versus continuing their current regimen. The goal is to see if DOR/ISL maintains virus suppression as effectively as BIC/FTC/TAF after 48 weeks without causing significant side effects.

Participant Groups

Group I: DOR/ISL and Placebo to BIC/FTC/TAF Experimental Treatment 2 Interventions

Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Group II: BIC/FTC/TAF and Placebo to DOR/ISL Active Control 2 Interventions

Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Two drugs regimens for HIV. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Predicting Factors of Plasma HIV RNA Undetectability after Switching to Co-Formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Experienced HIV-1 Patients: A Multicenter Study. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Outcomes After Switching to BIC/FTC/TAF in Patients with Virological Failure to Protease Inhibitors or Non-Nucleoside Reverse Transcriptase Inhibitors: A Real-World Cohort Study. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Simplifying protease inhibitor therapy with once-daily dosing of saquinavir soft-gelatin capsules/ritonavir (1600/100 mg): HIVNAT 001.3 study. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

HIV-1 Resistance to Islatravir/Tenofovir Combination Therapy in Wild-Type or NRTI-Resistant Strains of Diverse HIV-1 Subtypes. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of the single tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). [2021]