Clinical trial NCT05700734: MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
Official title: A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV-1
Human Immunodeficiency Virus 1
Immunodeficiency Virus Type 1, Human
Human Immunodeficiency Virus Type 1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
timeFrame: Baseline and 168 hours post-dose
measure: Percentage of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to 36 days
measure: Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)
timeFrame: Up to 36 days
Secondary outcomes:
measure: Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)
timeFrame: At protocol specific timepoints up to 168 hours post-dose
measure: Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Concentration at 168 Hours Post-dose (C168) of MK-8558
timeFrame: 168 hours post-dose
measure: Maximum Concentration (Cmax) of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Half Life (t1/2) of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
measure: Terminal t1/2 of MK-8558
timeFrame: At protocol specific time points up to 504 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: