MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

• Status: Not yet recruiting
• Trial end date: 2023-02-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL.

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

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• Is in good health other than HIV-1 infection

• Is documented HIV-1 positive

• Is ART-naïve, which is defined as not having received any investigational or marketed antiretroviral agent within the 30 days prior to study drug administration

• Is willing to receive no other ART for the monitoring period of this study

• If male, agrees to the following during the intervention period and for at least 8 weeks after the last dose of study intervention:

• Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR

• Uses contraception unless confirmed to be azoospermic

• A female participant is eligible to participate if not pregnant or breastfeeding, and at least one of the following applies:

• Is not a woman of childbearing potential (WOCBP)

• Is a WOCBP and uses a highly effective contraceptive, has a negative pregnancy test within 24 hours of study intervention administration, abstains from breastfeeding for at least 56 days after study intervention, and has medical/menstrual/recent sexual activity reviewed by the investigator to decrease the risk of an early undetected pregnancy

Exclusion Criteria:

• Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases

• Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years

• Has a history of cancer (malignancy) other than adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other malignancy that has been successfully treated and unlikely to recur for the duration of the study in the opinion of the investigator

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

• Is positive for hepatitis B surface antigen

• Has a history of chronic hepatitis C unless there has been documented cure

• Has 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

• Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit

• Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit

• Is an excessive smoker (ie, more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day

• 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. Participants who consume 4 servings of alcoholic beverages per day may be enrolled at the discretion of the investigator

• 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

• Has a positive urine drug screen (except for cannabis) at screening and/or predose; rechecks are allowed