HIV-1 Infection
Conditions
Brief summary
The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Interventions
DRUGUlonivirine
MK-8507 administered as a single oral dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). Male participants with female partner of childbearing potential agrees to use a medically acceptable method of contraception during the study and 90 days after receiving study drug. * Body mass index \<=35 kg/m\^2 * Other than HIV infection, baseline health judged to be stable at screening and/or prior to administration of study drug * No clinically-significant electrocardiogram abnormality * Documented to be HIV-1 positive as determined by a positive enzyme-linked immunosorbent assay (ELISA) or quantitative polymerase chain reaction (PCR) result with confirmation * Has a screening plasma Cluster of Differentiation (CD4) T-cell count of \>200 /mm\^3 * Has a plasma HIV-1 RNA \>= 10,000 copies/mL within 30 days before administration of study drug * ART-naive, defined as never having received any ART agent, or have received \<=30 consecutive days of an investigational ART agent, excluding non-nucleoside reverse transcriptase inhibitors (NNRTIs), or have received \<=60 consecutive days of combination ART, excluding NNRTIs * Has not received an investigational agent or licensed ART within 30 days of study drug administration * Diagnosed with HIV-1 infection \>=3 months before screening * Willing to receive no other ART for the duration of the study * Has no evidence of mutations conferring resistance to NNRTIs at screening
Exclusion criteria
* Mentally or legally institutionalized or incapacitated, has significant emotional problems, or has a history of clinically significant psychiatric disorder * History of clinically significant and not stably controlled abnormalities or diseases * History of cancer, with the exceptions of 1) adequately-treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, 2) other malignancies which have been successfully treated \>=10 years before screening, or 3) participants who are highly unlikely to sustain a recurrence for the duration of the study * History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food * Positive for hepatitis B surface antigen * History of chronic hepatitis C virus (HCV) unless there has been a documented cure or a negative HCV viral load * Had major surgery, or donated or lost \>=1 unit (\ 500 mL) of blood within 4 weeks before screening * Participated in another investigational trial within 4 weeks before administration of study drug * Unable to refrain from or anticipates the use of any medication beginning 4 weeks before administration of study drug and throughout the trial. Certain medications are permitted. * Consumes \>3 glasses of alcoholic beverages per day (1 glass is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits). Participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator. * Consumes \>10 cigarettes per day and is unwilling to restrict smoking to \<=10 cigarettes per day * Regular user of any illicit drugs or has a history of drug abuse (including alcohol) within 2 years * Has an immediate family member who is investigational site or sponsor staff directly involved with the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Plasma HIV-1 RNA | 168 hours (7 days) postdose |
| Number of Participants with One or More Adverse Experiences | Up to 21 days postdose |
Secondary
| Measure | Time frame |
|---|---|
| Time of Maximum Plasma Concentration of Ulonivirine (Tmax) | Up to 336 hours postdose |
| Plasma Concentration of Ulonivirine at 168 Hours Postdose (C168hr) | 168 hours postdose |
| Area Under the Plasma Concentration-Time Curve of Ulonivirine (AUC0-168hr) | Up to 168 hours postdose |
| Apparent Terminal Half-Life (T1/2) of Plasma Ulonivirine | Up to 336 hours postdose |
| Plasma Concentration of Ulonivirine at 336 Hours Postdose (C336hr) | 336 hours postdose |
| Maximum Plasma Concentration of Ulonivirine (Cmax) | Up to 336 hours postdose |
Outcome results
None listed