MK-4646 + ARTs for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new HIV-1 treatment called MK-4646 (experimental treatment) to assess its interaction with standard HIV medications. Researchers aim to determine if MK-4646 alters the blood levels of these medications and if it is safe and well-tolerated. Participants will be healthy individuals without major health issues and with a BMI between 18 and 32. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since the study involves healthy participants and tests interactions with specific HIV treatments, it's possible you may need to pause other medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment MK-4646, when combined with either dolutegravir (DTG) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), is generally well-tolerated by healthy participants. Previous studies indicate that MK-4646 does not cause significant side effects, and participants typically tolerate it well.
Dolutegravir (DTG) is already approved for treating HIV-1 and has a well-established safety record. Research shows it is safe and effective for many individuals. Similarly, BIC/FTC/TAF is also approved for HIV-1 treatment and is considered safe and well-tolerated. Long-term studies have found that most individuals do not experience serious side effects with these medications.
In summary, both MK-4646 and the ART combinations (DTG and BIC/FTC/TAF) have promising safety data. Participants usually tolerate these treatments without major health issues.12345Why are researchers excited about this trial's treatments?
Researchers are excited about MK-4646 combined with antiretroviral therapies (ARTs) for HIV treatment due to its potential to enhance treatment efficacy. Unlike standard HIV treatments that rely on known ARTs like dolutegravir or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) alone, MK-4646 introduces a novel active ingredient that could work synergistically with these existing drugs. This combination could potentially improve viral suppression rates or provide benefits in terms of dosing or side effect profiles. The excitement lies in the possibility of offering a more effective or tolerable treatment option for individuals living with HIV.
What evidence suggests that this trial's treatments could be effective for HIV-1?
This trial will evaluate the effectiveness of MK-4646 when combined with other treatments. Studies have shown that dolutegravir (DTG) effectively treats HIV-1, outperforming treatments like Atripla and controlling the virus in most patients. DTG has successfully reduced the virus to undetectable levels in the blood.
Research on the combination of bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) also shows high effectiveness, successfully lowering the virus in the blood across different patient groups. Both DTG and BIC/FTC/TAF are known to be safe and well-tolerated, making them strong options for managing HIV-1.
This trial will test MK-4646 in combination with either DTG or BIC/FTC/TAF to determine if it can enhance their effectiveness without causing safety issues.16789Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI between 18 and 32 who do not have any significant health problems. Participants should not have HIV or other major illnesses.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of MK-4646 coadministered with either BIC/FTC/TAF or DTG
Pharmacokinetic Monitoring
Blood samples are collected to determine pharmacokinetic parameters such as AUC, Cmax, and Tmax for up to 72 hours post-dose
Follow-up
Participants are monitored for safety and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- MK-4646
Trial Overview
The study tests how a new drug, MK-4646, interacts with standard HIV medicines (Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir) in healthy people. It looks at safety and how these drugs affect each other's levels in the blood.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).
Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
Participants will receive a single oral dose of dolutegravir (DTG).
Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
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
Citations
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine ...
Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG). MK-4646 is a trial medicine designed to treat HIV ...
Effectiveness and safety of bictegravir/emtricitabine ... - PMC
BICtegravir Single Tablet Regimen is a multiregional, observational cohort study assessing the effectiveness and safety of bictegravir/ ...
3.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/bic-ftc-taf-safe-and-effective-in-patients-with-hiv-aged-50-years-and-older/BIC/FTC/TAF Safe and Effective in Patients With HIV Aged ...
BIC/FTC/TAF was safe and effective among treatment-naive and virologically suppressed patients with HIV aged 50 years and older.
4.
schw-aerztej.healthbooktimes.org
schw-aerztej.healthbooktimes.org/article/117273-long-term-treatment-success-with-bictegravir-emtricitabine-tenofovir-alafenamide-bic-ftc-tafLong-Term Treatment Success with Bictegravir/Emtricitabine ...
The experts agreed that the BIC/FTC/TAF regimen is highly suitable for everyday use, showing efficacy and tolerability across various patient groups.
Biktarvy® (BIC/FTC/TAF) Efficacy by Adherence Subgroups
PWH who were treated with BIC/FTC/TAF had high rates of virologic suppression (96–99%, using LOCF imputation) at Weeks 48, 96, and 144, regardless of the level ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-clinical-trial-of-mk-4646-with-bictegravir-emtricitabine-tenofovir-alafenamide-and-dolutegravir-inA Clinical Trial of MK-4646 With Bictegravir/Emtricitabine ...
If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time. About the safety of MK-4646 and if ...
Effectiveness and safety of tenofovir alafenamide/emtricitabine ...
Estimated TAF/FTC/BIC durability was 84.8% at 12 months, 75.5% at 24 months. •. Few toxicities led to TAF/FTC/BIC interruptions among the study cohort. Keywords ...
8.
eatg.org
eatg.org/hiv-news/bic-ftc-taf-safe-and-effective-in-patients-with-hiv-aged-50-years-and-older/BIC/FTC/TAF safe and effective in patients with HIV aged ...
Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe, effective, and well-tolerated in patients with HIV infection aged 50 ...
Biktarvy® (BIC/FTC/TAF) Efficacy and Safety in Females
Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 ...
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