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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: HIV-1 Infection

Treatments: Drug: Comparator: Placebo; Drug: MK6186

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152255

2010-020829-41 (EudraCT Number)

2010_542

6186-007

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 8 patient groups, including a placebo group

Panel A - MK6186 40 mg

Experimental group

Description:

MK6186 40 mg

Treatment:

Drug: MK6186

Panel A - Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo

Panel B - MK6186 150 mg

Experimental group

Description:

MK6186 150 mg

Treatment:

Drug: MK6186

Panel B - Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo

Panel C - MK6186 <=150 mg

Experimental group

Description:

MK6186 \<=150 mg

Treatment:

Drug: MK6186

Panel C - Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo

Panel D - MK6186 <=150 mg

Experimental group

Description:

MK6186 \<=150 mg

Treatment:

Drug: MK6186

Panel D - Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo