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

This study has been terminated.
(primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00443703
First received: March 2, 2007
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
HIV Infection
Drug: MK0518 (raltegravir)
Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )
Drug: Comparator: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 A

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: Week 24 ] [ 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 ]
    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 Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
  • Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (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 Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
  • Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (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 ]
    Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.


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-High-Density Lipoprotein Cholesterol (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 Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (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 ]
    Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.


Enrollment: 352
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )
Drug: MK0518 (raltegravir)
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
Other Names:
  • MK0518
  • raltegravir
Drug: Comparator: placebo
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
Active Comparator: 2
Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)
Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
Other Name: KALETRA
Drug: Comparator: placebo
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443703

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00443703     History of Changes
Other Study ID Numbers: 2007_507, MK0518-032
Study First Received: March 2, 2007
Results First Received: October 16, 2009
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Ritonavir
Lopinavir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014