Trial record 22 of 31 for:    " October 12, 2011":" November 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466985
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 participants.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Doravirine Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change from baseline in HIV-RNA viral load [ Time Frame: Baseline and Day 7 ]

Secondary Outcome Measures :
  1. Observed Concentration at 24 hours post-dose (C24 hr) following administration of doravirine [ Time Frame: 24 hours after dosing on Days 1-7 ]
  2. 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 ]
  3. Maximum Observed Concentration (Cmax) following administration of doravirine [ Time Frame: Days 1-7 ]
  4. Time to Maximum Observed Concentration (Tmax) following administration of doravirine [ Time Frame: Days 1-7 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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