Human Immunodeficiency VirusPhase 2NCT05115838
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
A Phase 2 study testing Islatravir in people with Human Immunodeficiency Virus and HIV, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, HIV
- What is being tested?
- Islatravir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2024to 2 Oct 2025
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Human Immunodeficiency Virus, HIV
- Being tested
- Islatravir, Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IslatravirDrug
Also called MK-8591
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
PlaceboDrug
Placebo implantable rod placed subdermally on the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Islatravir 47 mg | Experimental | 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. Receives: Drug: Islatravir |
| Islatravir 52 mg | Experimental | 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. Receives: Drug: Islatravir |
| Islatravir 57 mg | Experimental | 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. Receives: Drug: Islatravir |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 weeks
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.
Measured: Up to 52 weeks
Secondary outcomes (2)
Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
Plasma ISL C12weeks will be determined.
Measured: Week 12
Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
Plasma ISL C52weeks will be determined.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start4 Jan 2024 (estimated)
- Primary completion2 Oct 2025 (estimated)
- Study completion2 Oct 2025 (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 VirusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT05115838
- Sponsor's protocol ID
- 8591-043
- Other IDs
- MK-8591-043, 2021-003414-39
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2021
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05115838
- Acronym / sponsor ID
- 8591-043
- Conditions
- Human Immunodeficiency Virus, HIV
- 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
- 4 Jan 2024 (estimated)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 2 Oct 2025 (estimated)
- First posted
- 10 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Islatravir 47 mg | Experimental | Drug: IslatravirParticipants 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. |
| Islatravir 52 mg | Experimental | Drug: IslatravirParticipants 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. |
| Islatravir 57 mg | Experimental | Drug: IslatravirParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
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-8591ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm. | Drug | Islatravir 47 mg, Islatravir 52 mg, Islatravir 57 mg |
| PlaceboPlacebo implantable rod placed subdermally on the upper arm. | Drug | Placebo |
Primary outcome
Percentage of participants with ≥1 adverse events (AEs)
Time frame: Up to 60 weeks
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.
Percentage of participants withdrawing from study treatment due to adverse event (AE)
Time frame: Up to 52 weeks
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.
2 secondary outcomes
Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
Time frame: Week 12
Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
Time frame: Week 52
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 24 Nov 2023.
- Merck Clinical Trials InformationLink provided by the sponsor.
- 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 and HIV, 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 7 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 24 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Percentage of participants with ≥1 adverse events (AEs) (time frame: Up to 60 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 24 Nov 2023.