MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Sex
Ages
Volunteers
Inclusion criteria
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Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.
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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).
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Is anti-retroviral therapy (ART)-naïve, which is defined as:
- Having never received any anti-retroviral agent; or
- ART-experienced but has not received any ART for HIV-1 infection within 60 days; or
- Has received pre-exposure prophylaxis (PrEP) treatment prior to diagnosis of HIV-infection but has not received any PrEP within 30 days.
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Is willing to receive no other ART prior to Day 11 post-dose of the study.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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