MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)

• Status: Not yet recruiting
• Trial end date: 2024-02-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.

• Has documented HIV-1 positive, as determined by a positive enzyme-linked immunosorbent assay (ELISA) or real-time quantitative polymerase chain reaction (QT-PCR) with confirmation (eg, Western Blot).

• Is anti-retroviral therapy (ART)-naïve, which is defined as:

1. Having never received any anti-retroviral agent; or

2. ART-experienced but has not received any ART for HIV-1 infection within 60 days; or

3. Has received pre-exposure prophylaxis (PrEP) treatment prior to diagnosis of HIV-infection but has not received any PrEP within 30 days.

• Is willing to receive no other ART prior to Day 11 post-dose of the study.

• Has a body mass index (BMI) ≤35 kg/m2.

Exclusion Criteria:

• Has acute (primary) HIV-1 infection.

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.

• Has remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma).

• Is mentally or legally incapacitated or has significant emotional problems.

• Has history of cancer (malignancy).

• Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e, systemic allergic reaction) to prescription or nonprescription drugs or food.

• Has positive hepatitis B surface antigen (HBsAg).

• Has a history of chronic hepatitis C unless there has been documented cure and/or participant with a positive serologic test for hepatitis C virus (HCV) has a negative HCV viral load (VL).

• Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.

• Has participated in another investigational study within 4 weeks.

• Has a clinically significant abnormality on the electrocardiogram (ECG) performed at the pre-study visit.

• Has been committed to an institution by way of official or judicial order.

• Is under the age of legal consent or not capable of giving consent.

• Does not agree to follow the smoking restrictions as defined by the clinical research unit (CRU).

• Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.

• Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.

• Is a regular user of any illicit drugs (not including cannabis) or has an history of drug (including alcohol) abuse within approximately 12 months.