Trial record 18 of 34 for:    " June 16, 2010":" July 16, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01152255
First received: June 25, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.


Condition Intervention Phase
HIV-1 Infection
Drug: MK6186
Drug: Comparator: Placebo
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 MK6186 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 plasma HIV-1 RNA [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
  • Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences [ Time Frame: through Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • C(24 hour) of MK6186 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - MK6186 40 mg
MK6186 40 mg
Drug: MK6186
Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
Placebo Comparator: Panel A - Placebo
placebo
Drug: Comparator: Placebo
Placebo tablets taken orally for seven day
Experimental: Panel B - MK6186 150 mg
MK6186 150 mg
Drug: MK6186
Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
Placebo Comparator: Panel B - Placebo
placebo
Drug: Comparator: Placebo
Placebo tablets taken orally for seven day
Experimental: Panel C - MK6186 <=150 mg
MK6186 <=150 mg
Drug: MK6186
Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
Placebo Comparator: Panel C - Placebo
placebo
Drug: Comparator: Placebo
Placebo tablets taken orally for seven day
Experimental: Panel D - MK6186 <=150 mg
MK6186 <=150 mg
Drug: MK6186
Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
Placebo Comparator: Panel D - Placebo
placebo
Drug: Comparator: Placebo
Placebo tablets taken orally for seven day

  Eligibility

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

Inclusion Criteria:

  • Other than HIV infection, patient's baseline health is judged to be stable
  • Patient is documented HIV-1 positive
  • Patient has not received an investigational agent or licensed ART with in the past 30 days

Exclusion Criteria:

  • Patient has a history of stroke, chronic seizures, or major neurological disease
  • Patient has a history of cancer
  • Patient has used any immune therapy agents or immunosuppressive therapy within the past month
  • Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
  • Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen
  • Patient consumes excessive amounts of alcohol (greater than 3 servings per day) or caffeine (greater than 6 servings per day)
  • Patient is an excessive smoker (more than 10 cigarettes per day)
  • Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152255

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01152255     History of Changes
Other Study ID Numbers: MK-6186-007, 2010_542
Study First Received: June 25, 2010
Last Updated: July 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
Treatment of HIV-1 Infection

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

ClinicalTrials.gov processed this record on July 23, 2014