Status:
COMPLETED
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infection
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01466985
Start Date
October 21 2011
End Date
April 10 2012
Last Update
February 15 2019
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