Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
