MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(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:
NCT00443729
First received: March 2, 2007
Last updated: October 15, 2013
Last verified: October 2013
  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
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 B

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: 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-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.


Other Outcome Measures:
  • Number of Patients With Serious CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
    Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose

  • Number of Patients With Drug-related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.

  • Number of Patients With Serious Drug-related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
    Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement

  • Number of Patients That Died by 24 Week Last Patient Last Visit [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued Due to CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
  • Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
  • Number of Patients With Drug-related LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
  • Number of Patients With Serious LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]
    Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose

  • Number of Patients That Discontinued Due to LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ] [ Designated as safety issue: Yes ]

Enrollment: 355
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Raltegravir & Placebo
Drug: Comparator: raltegravir
raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
Drug: Comparator: placebo
lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
Active Comparator: 2
Lopinavir (+) Ritonavir & Placebo
Drug: Comparator: lopinavir (+) ritonavir
lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment
Drug: Comparator: placebo
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 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 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: NCT00443729     History of Changes
Other Study ID Numbers: 0518-033, 2007_508
Study First Received: March 2, 2007
Results First Received: October 12, 2009
Last Updated: October 15, 2013
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 April 22, 2014