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

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 2

Conditions: Human Immunodeficiency Virus; HIV

Treatments: Drug: Islatravir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05115838

MK-8591-043 (Other Identifier)

2021-003414-39 (EudraCT Number)

8591-043

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Islatravir 47 mg

Experimental group

Description:

Participants receive an ISL 47 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Treatment:

Drug: Islatravir

Islatravir 52 mg

Experimental group

Description:

Participants receive an ISL 52 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Treatment:

Drug: Islatravir

Islatravir 57 mg

Experimental group

Description:

Participants receive an ISL 57 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Treatment:

Drug: Islatravir

Placebo

Placebo Comparator group

Description:

Participants receive a placebo implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.

Treatment:

Drug: Placebo