Safety, Tolerability and Antiretroviral Activity of a Single Oral Dose of MK-8527 in ART‑Naïve Adults with HIV‑1

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What is this study about?

The study focuses on people infected with HIV-1, a virus that attacks the immune system and can lead to AIDS if not treated. The medication being tested is an oral capsule called MK-8527, which is taken as a single dose. The drug is intended to work as part of ART, which means a regimen of medicines that stop the virus from multiplying.

The purpose of the study is to assess how well the single dose reduces the amount of virus in the blood and to determine whether the medication is safe and tolerable. Participants will receive the study drug and then be monitored over several days for any side effects, such as feeling unwell or having abnormal lab results, and for changes in the level of viral genetic material (RNA) in their blood. The trial involves a short period of observation after dosing, during which researchers will collect blood samples to see how the drug is processed by the body and how it affects the virus.

1 enrollment and consent

after joining the study, you sign a consent form that explains the purpose of the trial and what will be required of you.

2 baseline assessments

a series of tests are performed to record your health status before receiving the study medication. this includes checking your hiv-1 viral load, blood chemistry, and other safety labs.

3 single oral dose of <b>mk-8527</b>

you take one hard capsule of mk-8527 by mouth. the capsule may contain either 1 mg or 10 mg of the active substance, depending on the dose group you are assigned to. the dose is taken only once during the trial.

4 initial monitoring after dose

you remain in the clinic for several hours after taking the dose so that staff can observe you for any immediate side effects.

5 blood sampling schedule

blood is drawn at specific times to measure the amount of mk-8527 in your body and to check your hiv-1 viral load. samples are collected before the dose (baseline) and then at approximately 1, 2, 4, 8, 24, 48, 72, and 168 hours after the dose.

6 follow‑up safety visits

you return to the clinic for additional safety checks, which may include a physical exam and laboratory tests, up to one week after the dose.

7 study completion

after the final assessments are finished, the study is considered complete for you. all data collected will be used to evaluate the safety and antiviral activity of mk-8527.

Who Can Join the Study?

Be generally healthy apart from having HIV-1 infection.
Have a confirmed (documented) diagnosis of HIV-1.
Be ART‑naïve, meaning you have not taken any approved antiretroviral (HIV) medicines before; if you used an HIV drug for prevention (PrEP) or in another study, you must have stopped it at least 30 days before starting the study medication.
Agree not to take any other antiretroviral (HIV) medicines during the time you are being monitored in the study.
If you are male, you must either avoid vaginal sex during the study and for at least 8 weeks after the last dose, or use birth control unless a doctor has confirmed you have no sperm (called azoospermic).
If you are female, you must not be pregnant or breastfeeding, and you must meet one of these conditions: you are not able to become pregnant (not a woman of childbearing potential), or if you can become pregnant (woman of childbearing potential), you must use a highly effective contraceptive, have a negative pregnancy test within 24 hours before the study drug, avoid breastfeeding for at least 56 days after the drug, and have your health and menstrual history reviewed by the study doctor to lower the chance of an early undetected pregnancy.

Who Cannot Join the Study?

Has a history of serious problems with any of the following body systems: endocrine (hormone glands), gastrointestinal (stomach or intestines), cardiovascular (heart or blood vessels), hematological (blood), hepatic (liver), immunological (immune system) that are not related to HIV, renal (kidneys), respiratory (lungs), genitourinary (urinary or reproductive organs), or major neurological (brain or nerves) diseases such as stroke or ongoing seizures.
Participated in another research study that used an experimental drug within the last 4 weeks (or within 5 half‑lives of that drug, whichever is longer) before the screening visit.
Smokes more than 10 cigarettes each day and is not willing to reduce smoking to 10 or fewer cigarettes per day.
Drinks more than 3 servings of alcohol each day (one serving is about one regular beer, a small glass of wine, or a single shot of spirits). Consuming 4 servings may be allowed only at the investigator’s discretion.
Consumes more than 6 servings of caffeinated drinks each day (one serving is roughly the amount of caffeine found in a standard cup of coffee, tea, cola, or energy drink).
Has a positive result on a urine drug screen, unless the drug is cannabis or a benzodiazepine that has been prescribed by a doctor.
Is mentally or legally unable to give consent, has serious emotional problems now or expected during the study, or has had a major psychiatric disorder (such as severe depression or psychosis) in the past 5 years.
Has a history of cancer (malignancy) other than fully treated non‑melanoma skin cancer, carcinoma in situ of the cervix, or other cancers that the doctor believes are cured and unlikely to return during the study.
Has multiple or severe allergies, or has ever had an anaphylactic reaction (a serious whole‑body allergic reaction) or a strong intolerance to prescription or over‑the‑counter medicines or foods.
Tests positive for hepatitis B surface antigen, indicating an active hepatitis B infection.
Has chronic hepatitis C infection unless it has been documented as cured.
Had major surgery or gave/lose about one unit of blood (≈500 mL) within 4 weeks before the screening visit.
Cannot avoid using any medicines—including prescription drugs, over‑the‑counter products, or herbal remedies—starting about 2 weeks (or 5 half‑lives) before the first dose and continuing throughout the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Icbhgttyeh Ndxflapk Dm Bsui Igrovlkqopv Pyozeqtetouil Bvna	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	13.10.2023

Trial locations

MK-8527 is an experimental pill that is being tested as a single‑dose treatment for people who have HIV‑1 and have not yet started regular antiretroviral therapy. In this study, participants take a hard capsule by mouth. The goal of using this medication is to see how well it can lower the amount of HIV in the body, and to check that it is safe and easy to tolerate for patients.

Investigated Diseases:

HIV infection

HIV-1 – HIV-1 is a virus that infects immune cells called CD4 T‑lymphocytes. After initial exposure, the virus multiplies rapidly and causes a brief flu‑like illness in many people. Over months to years, the infection gradually reduces the number of CD4 cells, weakening the body’s ability to fight everyday germs. As the immune system weakens, the condition can advance from an asymptomatic phase to a stage where infections and cancers that are normally rare become common.

Trial ID:

2023-503682-39-00

Protocol code:

MK-8527-004

Trial Phase:

Human Pharmacology (Phase I) – Other

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Safety, Tolerability and Antiretroviral Activity of a Single Oral Dose of MK-8527 in ART‑Naïve Adults with HIV‑1

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?