Clinical Trials


A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)

This study has been completed
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Merck Sharp & Dohme Corp. Identifier

First received: November 4, 2011
Last updated: October 1, 2015
Last Verified: October 2015
History of Changes


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.

Condition Intervention Phase
HIV-1 Infection

Drug : Doravirine
Drug : Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-1439 in HIV-1 Infected Patients

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Change from baseline in HIV-RNA viral load [ Time Frame: Baseline and Day 7 ]
Secondary Outcome Measures:
  • Observed Concentration at 24 hours post-dose (C24 hr) following administration of doravirine [ Time Frame: 24 hours after dosing on Days 1-7 ]
  • Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) following administration of doravirine [ Time Frame: From Hour 0 to Hour 24 after dosing on Days 1-7 ]
  • Maximum Observed Concentration (Cmax) following administration of doravirine [ Time Frame: Days 1-7 ]
  • Time to Maximum Observed Concentration (Tmax) following administration of doravirine [ Time Frame: Days 1-7 ]

Enrollment: 18
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Panel A doravirine

Drug: Doravirine

Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).

Experimental: Panel B doravirine
Panel B 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.
Drug: Doravirine

Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).

Experimental: Panel C doravirine
Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.
Drug: Doravirine

Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).

Experimental: Panel A, B, C Placebo
Participants on each Panel will be randomized to receive placebo.
Drug: Placebo

Placebo tablets once daily for 7 days.



Ages Eligible for Study: 18 Years to 55 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  


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 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

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT01466985

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01466985   History of Changes  
Other Study ID Numbers: 1439-005  
Study First Received: November 4, 2011  
Last Updated: October 1, 2015 processed this data on July 20, 2018
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