Doravirine/Islatravir for Healthy Subjects

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Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Neurological, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe the effects of two medications, doravirine and islatravir, in the bodies of healthy breastfeeding women. Researchers are determining whether these drugs appear in breast milk. Participants will take a tablet containing both medications once daily for seven days. Women who are at least six weeks postpartum and can pump breast milk are suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants an opportunity to contribute to early-stage medical research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if 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 treatment is likely to be safe for humans?

Research shows that the combination of doravirine and islatravir is generally well-tolerated. Studies have found that this treatment effectively controls the virus with few side effects. The most common side effect was headache, affecting about 10.4% of participants. Other side effects were minor, with no major changes in weight or body shape. Additionally, there were no significant effects on blood fats. Overall, previous trials have shown doravirine and islatravir to be safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard HIV treatments, which often involve a combination of several pills, Doravirine/Islatravir is unique because it offers a once-daily, fixed-dose combination tablet. This simplifies the treatment regimen, potentially improving adherence and making it easier for patients to manage their condition. Researchers are particularly excited about Islatravir, a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), which works differently by blocking the HIV lifecycle at an early stage, potentially offering enhanced effectiveness and reducing the chance of resistance. This innovative approach represents a promising step forward in HIV care.

What evidence suggests that this treatment might be an effective treatment for healthy subjects?

Research has shown that the combination of doravirine and islatravir effectively treats HIV-1. Studies have found that this combination helps control the virus in the body. Some trials demonstrated that it works as well as other standard treatments, with no major differences in effectiveness. Patients in these studies experienced minimal changes in weight and body shape, suggesting it is generally well-tolerated. Overall, doravirine and islatravir have successfully managed HIV-1 in different patient groups. ^{2 5 6 7 8}

Who 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 lactating women who are at least 6 weeks postpartum after delivering a healthy baby. Participants must be able to express breast milk using an electric pump and do so multiple times over a day following the study drug administration.

Inclusion Criteria

I gave birth to a healthy baby more than 6 weeks ago.

I can and will use an electric pump to express breast milk as required for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7

1 week

Follow-up

Participants are monitored for pharmacokinetics of DOR and ISL in breast milk and plasma

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Doravirine/Islatravir

Trial Overview The study is testing Doravirine (DOR) and Islatravir (ISL) in healthy breastfeeding women. It aims to understand how these drugs behave in the body over time and if they can be found in breast milk.

How Is the Trial Designed?

Group I: DOR/ISL Experimental Treatment 1 Intervention

Participants will receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41037024/

Efficacy and safety of doravirine/islatravir in heavily ... Conclusions: DOR/ISL plus OBT improved HIV-1 suppression in HTE adults living with HIV-1 and was generally well tolerated. Clinicaltrialsgov: ...

2. merck.com merck.com/news/merck-announces-new-data-from-phase-3-trials-evaluating-the-investigational-once-daily-oral-two-drug-regimen-of-doravirine-islatravir-dor-isl-in-adults-with-virologically-suppressed-hiv-1-infecti/

Merck Announces New Data from Phase 3 Trials ... DOR/ISL data presented show minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the ...

3. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(24)00031-6/abstract

Switch to fixed-dose doravirine (100 mg) with islatravir (0· ... Switching to single-tablet doravirine (100 mg) and islatravir (0·75 mg) maintained viral suppression up to week 48 and was non-inferior to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04233216

NCT04233216 | Doravirine/Islatravir (DOR/ISL) in Heavily ... This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose ...

5. academic.oup.com academic.oup.com/cid/article/81/2/322/8074956

Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With ... Doravirine/islatravir (100/0.75 mg) was noninferior to bictegravir/emtricitabine/tenofovir alafenamide in suppressing human immunodeficiency virus type 1 (

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35972855/

Brief Report: Efficacy and Safety of Oral Islatravir Once ... Conclusions: Treatment regimens containing islatravir and doravirine maintained viral suppression through week 96 and were well tolerated regardless of dose.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04223778

Study Details | NCT04223778 | Safety and Efficacy of a ... 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 ...

8. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/drugs/islatravir/patient

Islatravir Patient Drug Record | NIH The safety profiles of doravirine/islatravir and Biktarvy were comparable through Week 48. Drug-related side effects occurred in 10.2% of doravirine/islatravir ...