HIVPhase 2EXPrESSIVE-18NCT07850609
A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)
A Phase 2 study testing Alimatravir in people with HIV, run by Merck Sharp & Dohme LLC.
Trial summary
The goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Alimatravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 2 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The main inclusion criteria include but are not limited to the following:
- Is confirmed human immunodeficiency virus (HIV)-uninfected
- Is a transgender or gender diverse (TGD) person, ie, a person whose gender identity differs from the sex that was assigned at birth
- Is on stable gender-affirming hormone therapy (GAHT) and does not intend to change therapy through 2 months after the last dose of study intervention
- Has a low likelihood of HIV exposure
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has evidence of acute or chronic hepatitis B infection
- Has a history of malignancy within 5 years of Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
About this study
Official title: Protocol Title: A Phase 2 Open-label Study to Evaluate the Safety and Pharmacokinetics of MK-8527 Oral Once-monthly in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of HIV-1 Exposure
The goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it.
- Conditions
- HIV
- Being tested
- Alimatravir
- Keywords
- Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlimatravirDrug
Also called MK-8527
11 mg tablets taken orally once monthly (qm) for a total of 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Alimatravir | Experimental | Alimatravir 11 mg will be taken once monthly (qm) Receives: Drug: Alimatravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 4 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 2 months
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax) of Alimatravir in Plasma
Plasma samples will be collected to determine the Cmax of alimatravir.
Measured: At designated time points (up to approximately 3 months)
Time to Maximum Plasma Concentration (Tmax) of Alimatravir in Plasma
Plasma samples will be collected to determine the Tmax of alimatravir.
Measured: At designated time points (up to approximately 3 months)
Plasma Trough Concentration (Ctrough) of Alimatravir
Plasma samples will be collected to determine the Ctrough of alimatravir.
Measured: At designated time points (up to approximately 3 months)
Plasma Estradiol Concentration
Blood samples will be collected to determine the plasma concentration of estradiol.
Measured: Up to approximately 6.5 months
Plasma Testosterone Concentration
Blood samples will be collected to determine the plasma concentration of testosterone.
Measured: Up to approximately 6.5 months
Plasma Dihydrotestosterone Concentration
Blood samples will be collected to determine the plasma concentration of dihydrotestosterone.
Measured: Up to approximately 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start29 Oct 2026 (estimated)
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- 80 participants (estimated)
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
- NCT07850609
- Sponsor's protocol ID
- 8527-018
- Acronym
- EXPrESSIVE-18
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Title: A Phase 2 Open-label Study to Evaluate the Safety and Pharmacokinetics of MK-8527 Oral Once-monthly in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of HIV-1 Exposure
- ClinicalTrials.gov ID
- NCT07850609
- Acronym / sponsor ID
- EXPrESSIVE-18 / 8527-018
- Conditions
- HIV
- Keywords
- Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (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 goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alimatravir | Experimental | Drug: AlimatravirAlimatravir 11 mg will be taken once monthly (qm) |
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 human immunodeficiency virus (HIV)-uninfected
- Is a transgender or gender diverse (TGD) person, ie, a person whose gender identity differs from the sex that was assigned at birth
- Is on stable gender-affirming hormone therapy (GAHT) and does not intend to change therapy through 2 months after the last dose of study intervention
- Has a low likelihood of HIV exposure
Key exclusion criteria (3 listed)
- Has evidence of acute or chronic hepatitis B infection
- Has a history of malignancy within 5 years of Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
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 |
|---|---|---|
| AlimatravirAlso: MK-852711 mg tablets taken orally once monthly (qm) for a total of 3 doses | Drug | Alimatravir |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 4 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
6 secondary outcomes
Maximum Plasma Concentration (Cmax) of Alimatravir in Plasma
Time frame: At designated time points (up to approximately 3 months)
Time to Maximum Plasma Concentration (Tmax) of Alimatravir in Plasma
Time frame: At designated time points (up to approximately 3 months)
Plasma Trough Concentration (Ctrough) of Alimatravir
Time frame: At designated time points (up to approximately 3 months)
Plasma Estradiol Concentration
Time frame: Up to approximately 6.5 months
Plasma Testosterone Concentration
Time frame: Up to approximately 6.5 months
Plasma Dihydrotestosterone Concentration
Time frame: Up to approximately 6.5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alimatravir in people with 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 4 months). 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 30 Sep 2026.