Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Other than having HIV-1, is in good health

• Is antiretroviral therapy (ART)-naïve

• If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening

• Is willing to receive no other ART prior to Day 8 post-dose of the trial

• If capable of producing sperm agrees to use contraception

• If assigned female sex at birth is not breastfeeding

• A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum), and uses a contraceptive method that is highly effective

Locations
Other Locations
Republic of Moldova
PMSI Republican Clinical Hospital T.Mosneaga ( Site 0002)
RECRUITING
Chisinau
Romania
ARENSIA Exploratory Medicine ( Site 0001)
RECRUITING
Bucharest
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2026-04-06
Participants
Target number of participants: 28
Treatments
Experimental: MK-4646 Panel A
MK-4646 160 mg every 24 hours (q24h) for 7 days
Experimental: MK-4646 Panel B
MK-4646 ≤460 mg q24h for 7 days
Experimental: MK-4646 Panel C
MK-4646 ≤460 mg q24h for 7 days
Experimental: MK-4646 Panel D
MK-4646 ≤460 mg every 12 hours (q12h) for 7 days
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov