A Study of 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: May 15, 2012
Last verified: May 2012
  Purpose

This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of MK-1439 as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.


Condition Intervention Phase
HIV-1 Infection
Drug: MK-1439
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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 MK-1439 Drug: MK-1439
MK-1439 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 MK-1439
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: MK-1439
MK-1439 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 MK-1439
Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.
Drug: MK-1439
MK-1439 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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01466985     History of Changes
Other Study ID Numbers: 1439-005, 2011-003508-19
Study First Received: November 4, 2011
Last Updated: May 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014