Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Drug: Placebo; Drug: Comparator: MK0518; Drug: MK0518

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105157

MK0518-005

2005_007

0518-005

Details and patient eligibility

About

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
• Patient must be currently on antiretroviral therapy (ART)

Exclusion criteria

• Patient less than 18 years of age
• Additional exclusion criteria will be discussed and identified by the study doctor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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179 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

MK0518 200 mg

Treatment:

Drug: Comparator: MK0518

2

Experimental group

Description:

MK0518 400 mg

Treatment:

Drug: MK0518

Drug: MK0518

3

Experimental group

Description:

MK0518 600 mg

Treatment:

Drug: MK0518

Drug: MK0518

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo