DOR/ISL for HIV
Trial Summary
Will I have to stop taking my current medications?
The trial involves switching from your current HIV medication to Doravirine/Islatravir (DOR/ISL). You will need to stop your current antiretroviral therapy to participate in this study.
What data supports the effectiveness of the drug Doravirine/Islatravir for HIV?
Combination antiretroviral therapy (cART), which includes drugs like Doravirine/Islatravir, has been shown to significantly reduce the amount of HIV in the blood and improve immune system health by increasing CD4+ cell counts. This type of therapy has also been effective in reducing HIV-related health issues and improving overall outcomes for people living with HIV.12345
Is DOR/ISL safe for humans?
What makes the drug Doravirine/Islatravir (DOR/ISL) unique for treating HIV?
Doravirine/Islatravir (DOR/ISL) is unique because it combines two drugs into a single regimen, potentially improving adherence by simplifying treatment. Doravirine is known for its improved resistance profile, and Islatravir is being explored for its novel mechanism of action, which may offer new benefits compared to existing treatments.1112131415
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.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with standard of care ART for 48 weeks, followed by 96 weeks of treatment with DOR/ISL
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment with DOR/ISL for up to an additional 96 weeks or until DOR/ISL is commercially accessible
Treatment Details
Interventions
- ART
- Doravirine/Islatravir
ART is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- HIV-1 infection
- HIV-2 infection
- HIV-1 infection
- HIV-2 infection
- HIV-1 infection
- HIV-2 infection
- HIV-1 infection
- HIV-2 infection
- HIV-1 infection
- HIV-2 infection
- HIV-1 infection
- HIV-2 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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