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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01466985
First received: November 4, 2011
Last updated: October 27, 2014
Last verified: October 2014

November 4, 2011
October 27, 2014
October 2011
April 2012   (final data collection date for primary outcome measure)
Change from baseline in HIV-RNA viral load [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01466985 on ClinicalTrials.gov Archive Site
  • Observed Concentration at 24 hours post-dose (C24 hr) following administration of doravirine [ Time Frame: 24 hours after dosing on Days 1-7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum Observed Concentration (Cmax) following administration of doravirine [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Time to Maximum Observed Concentration (Tmax) following administration of doravirine [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Observed Concentration at 24 hours post-dose (C24 hr) following administration of MK-1439 [ Time Frame: 24 hours after dosing on Days 1-7 ] [ Designated as safety issue: No ]
  • Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) following administration of MK-1439 [ Time Frame: From Hour 0 to Hour 24 after dosing on Days 1-7 ] [ Designated as safety issue: No ]
  • Maximum Observed Concentration (Cmax) following administration of MK-1439 [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Time to Maximum Observed Concentration (Tmax) following administration of MK-1439 [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-1439 in HIV-1 Infected Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV-1 Infection
  • 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).
  • Drug: Placebo
    Placebo tablets once daily for 7 days.
  • Experimental: Panel A doravirine
    Intervention: Drug: Doravirine
  • 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.
    Intervention: Drug: Doravirine
  • Experimental: Panel C doravirine
    Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.
    Intervention: Drug: Doravirine
  • Experimental: Panel A, B, C Placebo
    Participants on each Panel will be randomized to receive placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01466985
1439-005, 2011-003508-19
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP