MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen - Tabular View

Tracking Information

First Received Date ^ICMJE

March 2, 2007

Last Updated Date

October 12, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Fasting Serum LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Fasting Serum HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
Median Percent Change From Baseline in Serum Triglyceride at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

HIV RNA at Week 24; safety and tolerability at week 24; change from baseline in key lipids at Week 12.

Change History

Complete list of historical versions of study NCT00443729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Non-HDL-C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Fasting Serum LDL-C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Mean Percent Change From Baseline in Fasting Serum HDL-C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Median Percent Change From Baseline in Serum Triglyceride at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Additional HIV RNA analysis and CD4 cell counts at Week 24 and at Week 48; safety and tolerability at week 48; change from baseline in key lipids at Week 24 and 48.

Descriptive Information

Brief Title ^ICMJE

MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen

Official Title ^ICMJE

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study B

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: Comparator: raltegravir
Drug: Comparator: placebo
Drug: Comparator: lopinavir (+) ritonavir
Drug: Comparator: placebo (unspecified)

Study Arms / Comparison Groups

Experimental: Raltegravir & Placebo
Active Comparator: Lopinavir (+) Ritonavir & Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

355

Completion Date

May 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient is at least 18 years of age
Patient is HIV positive
Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/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 is 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00443729

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_508, MK0518-033

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP