Health Trials

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

ConditionsHuman Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age16-30
SponsorMerck Sharp & Dohme LLC

About this trial

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 better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results

Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)

Was assigned female sex at birth and is cisgender.

Weighs ≥35 kg

Disqualifiers

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 cervical cancer

Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time

Trial design

Design model

Parallel

Treatments tested in this trial

  • MK-8527

    Drug

    Oral tablet

  • Emtricitabine/tenofovir disoproxil (FTC/TDF)

    Drug

    Oral tablet

  • Placebo matched to MK-8527

    Drug

    Placebo oral tablet matched to MK-8527

  • Placebo matched to FTC/TDF

    Drug

    Placebo oral tablet matched to FTC/TDF

Treatment groups

4,580 Participants
are divided into 2 treatment groups
Group A: MK-8527 + Placebo to FTC/TDFExperimental treatment 2 interventions
Group B: FTC/TDF + Placebo to MK-8527Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

The number of participants with adjudicated HIV-1 infection will be presented.

Time frame
Up to ~2 years
2

Number of Participants who Experience At Least One 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. The number of participants that experienced AEs will be presented.

Time frame
Up to ~2 years
3

Number of Participants who Discontinue Study Intervention Due to an 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. The number of participants that discontinued study intervention due to an AE will be presented.

Time frame
Up to ~2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov
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