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Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies
This study has been completed.

First Received on March 8, 2005.   Last Updated on June 17, 2010   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00105157
  Purpose

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.


Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome
 Drug: Comparator: MK0518
Drug: MK0518
Drug: Placebo
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency
MedlinePlus related topics: HIV/AIDS
Drug Information available for: Raltegravir Raltegravir potassium
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients


Secondary Outcome Measures:
  • Number of Patients With Virologic Responses at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24

  • Change From Baseline in CD4 Cell Count at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)

  • Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) 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 product, whether or not considered related to the use of the product

  • Number of Patients With Serious CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ 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 at 48 Weeks [ Time Frame: 48 weeks ] [ 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 judgment) CAEs

  • Number of Patients With Serious Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ 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 judgment.

  • Number of Patients That Died by 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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 product, whether or not considered related to the use of the product

  • Number of Patients With Drug-related LAEs at 48 Weeks [ Time Frame: 48 weeks ] [ 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 judgment) LAEs

  • Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients Discontinued With Drug-related LAEs at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) 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 product, whether or not considered related to the use of the product

  • Number of Patients With Serious CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ 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 at 96 Weeks [ Time Frame: 96 weeks ] [ 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 judgment) CAEs

  • Number of Patients With Serious Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ 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 judgment.

  • Number of Patients That Died by 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    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 product, whether or not considered related to the use of the product

  • Number of Patients With Drug-related LAEs at 96 Weeks [ Time Frame: 96 weeks ] [ 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 judgment) LAEs

  • Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients Discontinued With Drug-related LAEs at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) 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 product, whether or not considered related to the use of the product

  • Number of Patients With Serious CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ 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 at 168 Weeks [ Time Frame: 168 weeks ] [ 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 judgment) CAEs

  • Number of Patients With Serious Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ 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 judgment.

  • Number of Patients That Died by 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
    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 product, whether or not considered related to the use of the product

  • Number of Patients With Serious LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ 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 Discontinued With Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ 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 judgment) LAEs

  • Number of Patients With Serious Drug-related LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ 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 Discontinued With LAEs at 168 Weeks [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 179
Study Start Date: March 2005
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0518 200 mg
 Drug: Comparator: MK0518
MK0518 oral tablets 200 mg b.i.d, for 24 weeks
Other Name: MK0518
Experimental: 2
MK0518 400 mg
 Drug: MK0518
MK0518 oral tablets 400 mg b.i.d, for 24 weeks
Other Name: MK0518
Experimental: 3
MK0518 600 mg
 Drug: MK0518
MK0518 oral tablets 600 mg b.i.d, for 24 weeks
Other Name: MK0518
Placebo Comparator: 4
Placebo
 Drug: Placebo
Placebo to MK0518, oral tablet b.i.d, for 24 weeks

  Eligibility

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

Inclusion Criteria:

  • Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
  • Patient must be currently on antiretroviral therapy (ART)

Exclusion Criteria:

  • Patient less than 18 years of age
  • Additional exclusion criteria will be discussed and identified by the study doctor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105157

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:
Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-9.

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00105157     History of Changes
Other Study ID Numbers: 2005_007, MK0518-005
Study First Received: March 8, 2005
Results First Received: September 14, 2009
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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