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

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ClinicalTrials.gov Identifier: NCT00443703
Recruitment Status : Terminated (primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
First Posted : March 6, 2007
Results First Posted : December 1, 2009
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
  2. Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks [ Time Frame: 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

  3. Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ]
  4. Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  5. Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  6. Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  7. Median Percent Change From Baseline in Serum Triglyceride at Week 12 [ Time Frame: Baseline and Week 12 ]
    Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.


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


Other Outcome Measures:
  1. Number of Patients With Serious CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    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

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

  3. Number of Patients With Serious Drug-related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    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

  4. Number of Patients That Died by 24 Week Last Patient Last Visit [ Time Frame: 24 Week last patient last visit ]
  5. Number of Patients That Discontinued Due to CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
  6. Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
  7. Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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

  8. Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs

  9. Number of Patients With Serious LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    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

  10. Number of Patients That Discontinued Due to LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
  11. Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks [ Time Frame: 24 Week last patient last visit ]
    Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443703


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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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: 0518-032
2007_507
First Posted: March 6, 2007    Key Record Dates
Results First Posted: December 1, 2009
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Raltegravir Potassium
 Protease Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors