DOR/ISL for HIV/AIDS

Recruiting at 88 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: BIC/FTC/TAF

Must not be taking: Immunosuppressives, Immune modulators

Disqualifiers: HIV-2, Hepatitis, Recent malignancy, 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

643 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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.

Inclusion Criteria

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

I am not pregnant or breastfeeding, and I either cannot become pregnant, am using birth control, or am not having sex.

Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening.

Exclusion Criteria

Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.

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

Female expects to conceive or donate eggs at any time during the study.

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 for 144 weeks

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants who benefit from their assigned intervention can continue treatment for an additional 24 weeks

24 weeks

Treatment Details

Interventions

• Bictegravir/Emtricitabine/Tenofovir Alafenamide
• Doravirine/Islatravir

Trial Overview 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.

Participant Groups

Group I: DOR/ISL Experimental Treatment 2 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/TAF Active Control 3 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.

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

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

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

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