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

HIV-1 Infection Clinical Trial

Official title:

A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01152255
• Other study ID #: 6186-007
• Secondary ID: 2010_542
• Status: Terminated
• Phase: Phase 1
• First received: June 25, 2010
• Last updated: October 16, 2015
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

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)
• Comparator: Placebo
Placebo tablets taken orally for seven day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in plasma HIV-1 RNA		Baseline and Day 7	No
Primary	Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences		through Day 21	Yes
Secondary	C(24 hour) of MK6186		Day 7	No