Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2