MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

Phase 3TerminatedNCT00443703

Merck Sharp & Dohme LLC352 enrolled

Overview

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

352

Conditions

HIV Infection

Interventions

MK0518 (raltegravir)DRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment

Comparator: KALETRA™ (lopinavir (+) ritonavir )DRUG

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.

Comparator: placeboDRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is at least 18 years of age * Patient is Human Immunodeficiency Virus (HIV) positive * Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen * Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy * Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen Exclusion Criteria: * Patient is or plans to become pregnant, or nursing a child * Patient plans to donate eggs or impregnate/donate sperm * Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy * Patient is currently receiving a second protease inhibitor in addition to KALETRA * Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids * Patient has used another experimental HIV-integrase inhibitor * Patient has a current (active) diagnosis of acute hepatitis due to any cause * Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study

Outcomes

Primary Outcomes

Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24

Time frame: Week 24

Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks

An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \& Co., Inc.) product, whether or not considered related to the use of the product

Time frame: 24 Week last patient last visit

Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12