Rifabutin + MK-4646 for HIV

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, MK-4646, to evaluate its interaction with Rifabutin, a drug used for treating tuberculosis (TB). Researchers aim to determine if the blood levels of MK-4646 change when taken alone versus with Rifabutin, and to ensure its safety and tolerability. Participants will either take MK-4646 alone or both MK-4646 and Rifabutin. The trial seeks healthy individuals with a body mass index (BMI) between 18 and 32, who have no serious past health issues. 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.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have examined the safety of MK-4646, a drug tested as a new treatment for HIV. These studies aimed to determine if people could take MK-4646 without issues and if it effectively reduced HIV virus levels in the blood.

Research combined MK-4646 with Rifabutin in healthy volunteers to assess how the two drugs interact and ensure their safety when used together.

As a Phase 1 trial, this is among the first times this drug combination is tested in humans. This phase is crucial for assessing safety and tolerability. The main goal is to ensure the treatments do not cause harmful side effects. Phase 1 trials typically involve a small number of participants to closely monitor any adverse reactions.

Although detailed safety data for this specific trial is not yet available, the process prioritizes participant safety. Researchers will carefully observe participants' reactions to the treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-4646 and Rifabutin for HIV treatment because of their unique combination approach. Unlike standard treatments that primarily focus on antiretroviral therapies, MK-4646 offers a novel mechanism potentially enhancing immune response. Rifabutin, typically used for preventing bacterial infections in immunocompromised patients, is combined here to explore its synergy with MK-4646, potentially boosting the overall efficacy. This innovative pairing could lead to more robust HIV management, offering hope for improved outcomes in patients.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that MK-4646 is a new drug under development for treating HIV. Early studies are examining its safety and its effect on the amount of HIV-1 virus in the blood. Although limited data exists on its efficacy, the drug is being tested for its potential to reduce virus levels. In this trial, participants will receive either MK-4646 alone or in combination with Rifabutin. Rifabutin, a well-known tuberculosis medication, works effectively with other antibiotics. Researchers are studying how MK-4646 interacts with Rifabutin in the body to determine if this combination could offer a new approach to treating HIV. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp and Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy individuals with a BMI between 18 and 32 kg/m2. It's designed to understand how a new HIV treatment, MK-4646, behaves in the body when taken alone or alongside Rifabutin, which is used to treat TB.

Inclusion Criteria

I am in good health overall.

My BMI is between 18 and 32.

The main

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

A single oral dose of MK-4646 is administered

1 day

1 visit (in-person)

Treatment Period 2

Rifabutin is administered daily, and a single oral dose of MK-4646 is administered on Day 14

16 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-4646
• Rifabutin

Trial Overview The study aims to measure levels of MK-4646 in blood when taken with or without Rifabutin and assess the safety and tolerability of these medications when administered together to healthy participants.

How Is the Trial Designed?

Group I: MK-4646 with Rifabutin Experimental Treatment 2 Interventions

Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14.

Group II: MK-4646 Experimental Treatment 1 Intervention

On Period 1 Day 1, a single oral dose of MK-4646 will be administered.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07042945

MK-4646 Multiple Dose Trial in Participants With Human ... The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07199452

A Study of Rifabutin and MK-4646 in Healthy Participants ... Study Overview. Brief Summary. Researchers have designed a new study medicine called MK-4646 as a new way to treat human immunodeficiency virus (HIV).

3. treatmentactiongroup.org treatmentactiongroup.org/cure/trials/

Research Toward a Cure Trials A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online ...

4. euclinicaltrials.eu euclinicaltrials.eu/ctis-public/view/2024-510899-20-00

2024-510899-20-00 MK-4646 Single Ascending Dose Study and DDI in Healthy Participants. EUCT number:2024-510899-20-00. Protocol code:MK-4646-001. Download clinical trial.

5. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/suboptimal-cd4-cell-recovery-adult-adolescent-arv.pdf

Suboptimal CD4 Cell Recovery Despite Viral Suppression The immunologic effects of maraviroc intensification in treated HIV-infected individuals with incomplete CD4+ T-cell recovery: a randomized ...

6. ctv.veeva.com ctv.veeva.com/study/mk-4646-multiple-dose-trial-in-participants-with-human-immunodeficiency-virus-type-1-hiv-1-mk464

MK-4646 Multiple Dose Trial in Participants With Human ... This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount.