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

ClinicalTrials.gov Identifier:

NCT01466985

First received: November 4, 2011

Last updated: May 15, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 4, 2011
Last Updated Date	May 15, 2012
Start Date ^ICMJE	October 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2011)	Change from baseline in HIV-RNA viral load [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01466985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 4, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of MK-1439 in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Official Title ^ICMJE	A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-1439 in HIV-1 Infected Patients
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	HIV-1 Infection
Intervention ^ICMJE	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). Drug: Placebo Placebo tablets once daily for 7 days.
Study Arm (s)	Experimental: Panel A MK-1439 Intervention: Drug: MK-1439 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. Intervention: Drug: MK-1439 Experimental: Panel C MK-1439 Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels. Intervention: Drug: MK-1439 Experimental: Panel A, B, C Placebo Participants on each Panel will be randomized to receive placebo. Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01466985
Other Study ID Numbers ^ICMJE	1439-005, 2011-003508-19
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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