Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

HIV Clinical Trial

Official title:

A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05115838
• Other study ID #: 8591-043
• Secondary ID: MK-8591-0432021-
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 4, 2024
• Est. completion date: October 2, 2025

Study information

• Verified date: November 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2, 2025
• Est. primary completion date: October 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Is in good health

• Is confirmed human immunodeficiency virus (HIV)-uninfected

• Is at low risk of HIV infection

• For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials

• For females, is not pregnant or breastfeeding and one of the following applies:

• Is not a participant of childbearing potential (POCBP)

• Is a POCBP and uses an acceptable contraception method or is abstinent

Exclusion Criteria:

• Has an active diagnosis of hepatitis (B or C) due to any cause

• Has a history of malignancy =5 years before signing informed consent

• Has a history or current evidence of any condition that might confound study results or interfere with study participation

• Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)

• Is taking or is expected to take immunosuppressants during the study

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Islatravir
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
• Placebo
Placebo implantable rod placed subdermally on the upper arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with =1 adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 60 weeks
Primary	Percentage of participants withdrawing from study treatment due to adverse event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to 52 weeks
Secondary	Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)	Plasma ISL C12weeks will be determined.	Week 12
Secondary	Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)	Plasma ISL C52weeks will be determined.	Week 52

External Links

•   Merck Clinical Trials Information