A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
Primary Purpose
Human Immunodeficiency Virus (HIV) Infections
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Islatravir
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) Infections
Eligibility Criteria
Inclusion Criteria:
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before allocation to study intervention.
- Is on stable GAHT and does not intend to change therapy through Week 4 of the study.
- Has a low-risk of HIV infection.
- Identifies with a gender that is different from that assigned at birth.
- A participant assigned female at birth is eligible if not pregnant or chest-feeding and is not of childbearing potential (POCBP) or: Is a POCBP and using an acceptable contraceptive method, or be abstinent from penile-vaginal intercourse with an individual capable of producing sperm (abstinent on a long term and persistent basis); a POCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; If a urine test cannot be confirmed as negative (e.g, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant assigned female at birth with an early undetected pregnancy; contraceptive use by participant assigned female at birth should be consistent with local regulations.
Exclusion Criteria:
- Has known current or chronic history of liver disease (e.g, non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction.
- Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ anal cancers.
- Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time (past or current use).
- Is currently participating in or has participated in a clinical study with an investigational compound or device, within 30 days before Day 1 through the duration of the study.
- Is expecting to conceive or donate eggs at any time during the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Islatravir
Arm Description
60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks
Outcomes
Primary Outcome Measures
Participants with one or more adverse events (AEs)
Number of participants with one or more AEs will be reported.
Participants with an AE leading to discontinuation of study intervention
Number of participants with an AE leading to discontinuation of study intervention will be reported.
Secondary Outcome Measures
Area Under the Curve (AUC) of plasma islatravir (ISL)
Area Under the Curve from time 0 to 672 hours post-dose (AUC0-672hr) of plasma islatravir (ISL) will be reported.
Maximum concentration (Cmax) of plasma ISL
Maximum concentration (Cmax) of plasma ISL will be reported.
Trough concentration (Ctrough) of plasma ISL
Trough concentration (Ctrough) of plasma ISL will be reported.
Apparent terminal half-life (t1/2) of plasma ISL
Apparent terminal half-life (t1/2) of plasma ISL will be reported.
Full Information
NCT ID
NCT05130086
First Posted
November 10, 2021
Last Updated
October 13, 2022
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05130086
Brief Title
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
Official Title
A Phase 2 Open-Label Study to Evaluate the Safety and Pharmacokinetics of Oral Islatravir Once-Monthly in Trans and Gender Diverse Individuals on Gender-Affirming Hormone Therapy and at Low-Risk for HIV-1 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Business Reasons
Study Start Date
October 17, 2022 (Anticipated)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for human immunodeficiency virus 1 (HIV-1) infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV) Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Islatravir
Arm Type
Experimental
Arm Description
60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Islatravir
Other Intervention Name(s)
MK-8591
Intervention Description
60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks
Primary Outcome Measure Information:
Title
Participants with one or more adverse events (AEs)
Description
Number of participants with one or more AEs will be reported.
Time Frame
Up to 26 weeks
Title
Participants with an AE leading to discontinuation of study intervention
Description
Number of participants with an AE leading to discontinuation of study intervention will be reported.
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC) of plasma islatravir (ISL)
Description
Area Under the Curve from time 0 to 672 hours post-dose (AUC0-672hr) of plasma islatravir (ISL) will be reported.
Time Frame
Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Title
Maximum concentration (Cmax) of plasma ISL
Description
Maximum concentration (Cmax) of plasma ISL will be reported.
Time Frame
Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Title
Trough concentration (Ctrough) of plasma ISL
Description
Trough concentration (Ctrough) of plasma ISL will be reported.
Time Frame
Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Title
Apparent terminal half-life (t1/2) of plasma ISL
Description
Apparent terminal half-life (t1/2) of plasma ISL will be reported.
Time Frame
Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants will include anyone who identifies with a gender that is different from the sex assigned at birth (e.g., transgender woman, transgender man, gender nonbinary, etc.), including those with differences in sex development (sometimes called intersex).
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before allocation to study intervention.
Is on stable GAHT and does not intend to change therapy through Week 4 of the study.
Has a low-risk of HIV infection.
Identifies with a gender that is different from that assigned at birth.
A participant assigned female at birth is eligible if not pregnant or chest-feeding and is not of childbearing potential (POCBP) or: Is a POCBP and using an acceptable contraceptive method, or be abstinent from penile-vaginal intercourse with an individual capable of producing sperm (abstinent on a long term and persistent basis); a POCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; If a urine test cannot be confirmed as negative (e.g, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant assigned female at birth with an early undetected pregnancy; contraceptive use by participant assigned female at birth should be consistent with local regulations.
Exclusion Criteria:
Has known current or chronic history of liver disease (e.g, non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction.
Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ anal cancers.
Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time (past or current use).
Is currently participating in or has participated in a clinical study with an investigational compound or device, within 30 days before Day 1 through the duration of the study.
Is expecting to conceive or donate eggs at any time during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
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