Human Immunodeficiency Virus (HIV) InfectionsPhase 2NCT05130086
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
A Phase 2 study testing Islatravir in people with Human Immunodeficiency Virus (HIV) Infections, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infections
- What is being tested?
- Islatravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2022to 25 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Being tested
- Islatravir
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IslatravirDrug
Also called MK-8591
60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Islatravir | Experimental | 60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks Receives: Drug: Islatravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with one or more adverse events (AEs)
Number of participants with one or more AEs will be reported.
Measured: Up to 26 weeks
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.
Measured: Up to 20 weeks
Secondary outcomes (4)
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.
Measured: 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
Maximum concentration (Cmax) of plasma ISL
Maximum concentration (Cmax) of plasma ISL will be reported.
Measured: 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
Trough concentration (Ctrough) of plasma ISL
Trough concentration (Ctrough) of plasma ISL will be reported.
Measured: 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
Apparent terminal half-life (t1/2) of plasma ISL
Apparent terminal half-life (t1/2) of plasma ISL will be reported.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start17 Oct 2022 (estimated)
- Primary completion25 Mar 2024 (estimated)
- Study completion25 Mar 2024 (estimated)
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130086
- Sponsor's protocol ID
- 8591-035
- Other IDs
- MK-8591-035
- Status last verified
- Oct 2022
- First submitted
- 10 Nov 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05130086
- Acronym / sponsor ID
- 8591-035
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (estimated)
- Primary completion
- 25 Mar 2024 (estimated)
- Study completion
- 25 Mar 2024 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Islatravir | Experimental | Drug: Islatravir60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IslatravirAlso: MK-859160 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks | Drug | Islatravir |
Primary outcome
Participants with one or more adverse events (AEs)
Time frame: Up to 26 weeks
Number of participants with one or more AEs will be reported.
Participants with an AE leading to discontinuation of study intervention
Time frame: Up to 20 weeks
Number of participants with an AE leading to discontinuation of study intervention will be reported.
4 secondary outcomes
Area Under the Curve (AUC) of plasma islatravir (ISL)
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
Maximum concentration (Cmax) of plasma ISL
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
Trough concentration (Ctrough) of plasma ISL
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
Apparent terminal half-life (t1/2) of plasma ISL
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Islatravir in people with Human Immunodeficiency Virus (HIV) Infections, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with one or more adverse events (AEs) (time frame: Up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.