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

Phase 3

Terminated

• Conditions: HIV Infection
• Interventions: Drug: MK0518 (raltegravir)

• Registration Number: NCT00443703
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Study Start: 2007-05
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2009-10-16
• Results First Submitted QC: 2009-10-16
• Results First Posted: 2009-12-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 352

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MK0518 (raltegravir)	Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks	24 Week last patient last visit	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
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12	Baseline and Week 12
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24	Week 24
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12	Baseline and Week 12
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12	Baseline and Week 12
Median Percent Change From Baseline in Serum Triglyceride at Week 12	Baseline and Week 12	Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24	Baseline and Week 24
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24	Baseline and Week 24
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	Baseline and Week 24
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	Baseline and Week 24
Median Percent Change From Baseline in Serum Triglyceride at Week 24	Baseline and Week 24	Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.