Trial record 14 of 28 for:
" November 02, 2011":" December 02, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
A Study of MK-1439 in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01466985
First received: November 4, 2011
Last updated: May 15, 2012
Last verified: May 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Merck:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| 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 May 22, 2013