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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00443729

Purpose

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

Condition	Intervention	Phase
HIV Infection	Drug: Comparator: raltegravir Drug: Comparator: placebo Drug: Comparator: lopinavir (+) ritonavir Drug: Comparator: placebo (unspecified)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cholesterol

Drug Information available for: Ritonavir Lopinavir Raltegravir

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	355
Study Start Date:	May 2007
Study Completion Date:	May 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Raltegravir & Placebo	Drug: Comparator: raltegravir raltegravir 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment Drug: Comparator: placebo lopinavir (+) ritonavir 400/100 mg PO b.i.d. Placebo for up to 48 weeks of treatment.
2: Active Comparator Lopinavir (+) Ritonavir & Placebo	Drug: Comparator: lopinavir (+) ritonavir lopinavir (+) ritonavir 400/100 mg PO b.i.d. twice daily for up to 48 weeks of treatment. Drug: Comparator: placebo (unspecified) raltegravir 400 mg PO b.i.d. Placebo for up to 48 weeks of treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443729

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_508, MK0518-033
Study First Received:	March 2, 2007
Results First Received:	October 12, 2009
Last Updated:	October 12, 2009
ClinicalTrials.gov Identifier:	NCT00443729 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

treatment experienced

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 20, 2009