A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Status and phase
Completed
Phase 1
Conditions
HIV-1 Infection
Treatments
Drug: Doravirine
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.
Enrollment
18 patients
Sex
Male
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosis of HIV-1-infection ≥3 months prior to screening
- Participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
- Body Mass Index (BMI) ≤35 kg/m^2
- Other than HIV infection, participant's baseline health is judged to be stable
- No clinically significant abnormality on electrocardiogram (ECG)
- Participant is ART-naïve (defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent (excluding an Non-Nucleoside Reverse Transcriptase Inhibitor [NNRTI]) or ≤60 consecutive days of combination ART not including an NNRTI)
- Participant is willing to receive no other ART for the duration of the treatment phase of this study.
Exclusion criteria
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, or genitourinary abnormalities or diseases
- History of clinically significant neoplastic disease
- Participant has used any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study
- Participant has one or more pre-existing risk factors for Torsades de Pointes (New York Heart Association Functional Classification II through IV heart failure, familial long-QT-syndrome, uncorrected hypokalemia, QTcF >470 msec)
- Participant requires or is anticipated to require chronic daily prescription medications
- Current (active) diagnosis of acute hepatitis due to any cause
- History of chronic Hepatitis C virus (HCV) unless there has been documented cure and/or patient with a positive serologic test for HCV has a negative HCV viral load.
- Positive Hepatitis B surface antigen
- Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort [Hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study, until the post-study visit
- Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
- Participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
- Participant is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day
- Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
- Participation in another investigational study within 4 weeks prior to the prestudy (screening) visit
- History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Current regular user (including use of any illicit drugs) or has a history of drug (including alcohol) abuse within approximately 1 year
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
18 participants in 3 patient groups
Panel A: Doravirine 25 mg or Placebo
Experimental group
Description:
Participants will receive oral doses of doravirine 25 mg or placebo once daily for 7 days.
Treatment:
Drug: Placebo
Drug: Doravirine
Panel B: Doravirine 200 mg or Placebo
Experimental group
Description:
Panel B (doravirine 200 mg or placebo once daily for 7 days) will initiate upon satisfactory review of safety and tolerability from Panel A, and all safety, tolerability and pharmacokinetic data from the study MK-1439-001.
Treatment:
Drug: Placebo
Drug: Doravirine
Panel C: Doravirine or Placebo
Experimental group
Description:
Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.
Treatment:
Drug: Placebo
Drug: Doravirine
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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