BridgeMD
New treatment option for Human Immunodeficiency Virus (HIV)
Official title A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
ClinicalTrials.gov ID: NCT07071623
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 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 to 30, women only. Healthy volunteers may be eligible.
You may be able to join if
- The main include but are not limited to the following:
- 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
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 cervical...
- 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 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
- 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 cervical cancer
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Homabay County, Homa Bay County, Kenya
- Thika, Kiambu County, Kenya
- Nairobi, Kisumu County, Kenya
- Kisumu, Kenya
- East London, Eastern Cape, South Africa
- Ndevana, Eastern Cape, South Africa
- Bloemfontein, Free State, South Africa
- Johannesburg, Gauteng, South Africa
- Johnnesburg, Gauteng, South Africa
- Pretoria, Gauteng, South Africa
- Chatsworth, KwaZulu-Natal, South Africa
- Durban, KwaZulu-Natal, South Africa
- Edendale, KwaZulu-Natal, South Africa
- Ladysmith, KwaZulu-Natal, South Africa
- Phoenix, KwaZulu-Natal, South Africa
- Pietermaritzburg, KwaZulu-Natal, South Africa
- Somkhele - Mtubatuba, KwaZulu-Natal, South Africa
- Verulam, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
- Khayelitsha, Western Cape, South Africa
+ 5 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 female, 16 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homabay County, Homa Bay County, Kenya; Thika, Kiambu County, Kenya; Nairobi, Kisumu County, Kenya; Kisumu, Kenya; East London, Eastern Cape, South Africa; Ndevana, Eastern Cape, South Africa and 19 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.