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New treatment option for Human Immunodeficiency Virus (HIV)
Official title A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
ClinicalTrials.gov ID: NCT07044297
What this study is testing
What is MK-8527?
MK-8527 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for human immunodeficiency virus (hiv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day About the safety of MK-8527 and if people tolerate it
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older. Healthy volunteers may be eligible.
You may be able to join if
- The main include but are not limited to the following:
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
- Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has...
- Weighs ≥35 kg
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has hypersensitivity or other contraindication to any component of the study interventions
- 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...
- Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
- Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
See the full eligibility criteria
- The main include but are not limited to the following:
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
- Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more...
- Weighs ≥35 kg
- The main exclusion criteria include but are not limited to the following:
- Has hypersensitivity or other contraindication to any component of the study interventions
- 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
- Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
- Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
- Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
- Is expecting to donate eggs at any time during the study
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Jackson, Mississippi, United States
- Newark, New Jersey, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Greensboro, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Columbia, South Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Los Angeles, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.