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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152255
First Posted: June 29, 2010
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences [ Time Frame: through Day 21 ]

Secondary Outcome Measures:
  • C(24 hour) of MK6186 [ Time Frame: Day 7 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152255


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01152255     History of Changes
Other Study ID Numbers: 6186-007
2010_542
First Submitted: June 25, 2010
First Posted: June 29, 2010
Last Update Posted: October 19, 2015
Last Verified: October 2015

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