Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01353898
First received: May 12, 2011
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo.


Condition Intervention Phase
HIV-1 Infection
Drug: MK-1972
Drug: Placebo to MK-1972
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1972 in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: From consent to 14 days after the last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline in plasma HIV-1 ribonucleic acid (RNA) for MK-1972 50 mg once daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for MK-1972 200 mg once daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for MK-1972 800 mg once daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for MK-1972 25 mg twice daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for MK-1972 100 mg twice daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for MK-1972 800 mg twice daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]
  • Change from baseline in plasma HIV-1 RNA for placebo twice daily [ Time Frame: Baseline and Day 10, 24-hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the curve from 0-24 hours (AUC[0-24]) for plasma concentration of MK-1972 in participants with HIV-1 infection versus historical data from healthy young male subjects [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1972 50 mg once daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Experimental: MK-1972 200 mg once daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Experimental: MK-1972 800 mg once daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Experimental: MK-1972 25 mg twice daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Experimental: MK-1972 100 mg twice daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Placebo Comparator: Placebo twice daily (Part I) Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Experimental: MK-1972 800 mg twice daily Drug: MK-1972
MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days
Placebo Comparator: Placebo twice daily (Part II) Drug: Placebo to MK-1972
Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) twice per day for 10 days

  Eligibility

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

Inclusion Criteria

  • Stable baseline health.
  • Appropriate use of contraception; condom protection with pregnant partners.
  • Documented HIV-1 positive
  • Anti-retroviral therapy (ART)-naïve, defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent, excluding an integrase inhibitor, or ≤60 consecutive days of combination ART excluding an integrase inhibitor.
  • No investigational agent or licensed ART within 30 days of study drug administration.
  • Diagnosis of HIV-1-infection ≥ 3 months prior to screening.

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.
  • Use of any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study.
  • Requirement for 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 Hepatitis C virus (HCV) has a negative HCV viral load.
  • Positive Hepatitis B surface antigen.
  • Refusal to stop using 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 (including washout intervals), until the post-study visit.
  • Consumption of 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.
  • Consumption of 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.
  • Smoker of more than 10 cigarettes/day unwilling to restrict smoking to ≤10 cigarettes per day.
  • Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) or participation in another investigational study within 4 weeks prior to screening.
  • History of significant multiple and/or severe allergies (including latex allergy), or an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
  • Current regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year. Patients with a positive cannabis test with no evidence of drug-dependency may be enrolled at the discretion of the investigator.
  • History of hepatic or gallbladder disease or history of clinically significant abnormalities in liver function tests, or history of Gilbert's Syndrome, or history of elevated unconjugated bilirubin.
  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: NCT01353898     History of Changes
Other Study ID Numbers: MK-1972-003
Study First Received: May 12, 2011
Last Updated: April 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 20, 2014