553 Participants Needed

DOR/ISL for HIV

Recruiting at 52 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Antiretrovirals
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

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?

Antiretroviral therapies, like DOR/ISL, can have side effects, including skin reactions and other adverse drug reactions, which may lead some people to stop treatment. It's important to monitor for these reactions and discuss any concerns with healthcare providers.678910

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

MD

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

Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
I have been on a stable HIV treatment for over 3 months with no past treatment failures.
I am not able to have children, or I use birth control or do not have penile-vaginal sex, and I have a negative pregnancy test.

Exclusion Criteria

I am infected with HIV-2.
I have an active hepatitis B infection.
I have taken long-acting HIV therapy before.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with standard of care ART for 48 weeks, followed by 96 weeks of treatment with DOR/ISL

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Up to 96 weeks

Treatment Details

Interventions

  • ART
  • Doravirine/Islatravir
Trial Overview The study compares the safety and effectiveness of switching to Doravirine/Islatravir (DOR/ISL) versus continuing with existing ART at keeping HIV-1 RNA below detectable levels after 48 weeks, aiming to prove DOR/ISL is just as good.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DOR/ISLExperimental Treatment1 Intervention
Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are treated with DOR/ISL for 144 weeks. Participants will have the option to continue in an optional study extension and receive DOR/ISL for up to an additional 96 weeks or until DOR/ISL is commercially accessible (whichever comes first).
Group II: ART + DOR/ISLActive Control2 Interventions
Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are first treated with standard of care (SOC) ART for 48 weeks, followed by 96 weeks of treatment with DOR/ISL Participants will have the option to continue in an optional study extension and receive DOR/ISL for up to an additional 96 weeks or until DOR/ISL is commercially accessible (whichever comes first).

ART is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection
🇺🇸
Approved in United States as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection
🇨🇦
Approved in Canada as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection
🇯🇵
Approved in Japan as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection
🇨🇳
Approved in China as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection
🇨🇭
Approved in Switzerland as Antiretroviral Therapy for:
  • HIV-1 infection
  • HIV-2 infection

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Findings from Research

Combination antiretroviral therapy (cART) is becoming increasingly effective due to the development of new antiretroviral agents and treatment regimens.
Despite these advancements, the long-term success of HIV/AIDS treatment is at risk due to the emergence of drug-resistant strains that can resist multiple agents and entire drug classes.
Basis of selection of first and second line highly active antiretroviral therapy for HIV/AIDS on genetic barrier to resistance: a literature review.Katusiime, C., Ocama, P., Kambugu, A.[2021]
Novel antiretroviral agents, such as capsid inhibitors and second-generation maturation inhibitors, show high potency and potential for extended-duration dosing, which could improve treatment adherence for people living with HIV.
Islatravir, a nucleoside reverse transcriptase translocation inhibitor, has demonstrated sustained drug levels in a phase I trial, while fostemsavir is now available for compassionate use in patients with multi-drug-resistant HIV, highlighting advancements in treatment options.
Novel Antiretroviral Agents.Cambou, MC., Landovitz, RJ.[2021]
Antiretroviral therapy (ART) is now recommended for all patients with HIV-1, with treatment strategies tailored based on factors like CD4+ T-lymphocyte count and presence of opportunistic infections, aiming to achieve an undetectable plasma viral load.
Initial ART should consist of three drugs, including two nucleoside reverse transcriptase inhibitors (NRTIs) and one additional drug, with integrase strand transfer inhibitors (INSTIs) being preferred for their efficacy in treatment regimens.
Executive summary of the GESIDA/National AIDS Plan Consensus Document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2015).Berenguer, J., Polo, R., Aldeguer, JL., et al.[2017]

References

Basis of selection of first and second line highly active antiretroviral therapy for HIV/AIDS on genetic barrier to resistance: a literature review. [2021]
Novel Antiretroviral Agents. [2021]
Antiretroviral therapy in previously untreated adults infected with the human immunodeficiency virus type I: established and potential determinants of virological outcome. [2005]
Changing morbidity of cutaneous diseases in patients with HIV after the introduction of highly active antiretroviral therapy including a protease inhibitor. [2018]
Changes in Cognitive Function Over 96 Weeks in Naive Patients Randomized to Darunavir-Ritonavir Plus Either Raltegravir or Tenofovir-Emtricitabine: A Substudy of the NEAT001/ANRS143 Trial. [2021]
Clinicoepidemiological study of adverse cutaneous drug reactions among immunocompromised children at a tertiary care hospital. [2023]
A Prospective Study on Impact of Early Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus-Positive Adults on Immunological Status and Adverse Events. [2022]
Adverse effects of antiretroviral treatment. [2008]
Prevalence of drug-drug interactions of antiretroviral agents in the private health care sector in South Africa. [2014]
Reporting and recording of adverse drug reactions of highly active antiretroviral therapy by HIV infected patients and healthcare professionals respectively in the Ethekwini Metropolitan of Kwa-Zulu Natal, South Africa: a cross-sectional and retrospective comparative study. [2023]
Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. [2021]
Executive summary of the GESIDA/National AIDS Plan Consensus Document on Antiretroviral Therapy in Adults Infected by the Human Immunodeficiency Virus (Updated January 2017). [2021]
Executive summary of the GESIDA/National AIDS Plan Consensus Document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2015). [2017]
14.United Statespubmed.ncbi.nlm.nih.gov
Combination antiretroviral therapy with raltegravir leads to rapid immunologic reconstitution in treatment-naive patients with chronic HIV infection. [2021]
Current status and prospects of HIV treatment. [2022]
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