Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00105157
First received: March 8, 2005
Last updated: November 27, 2013
Last verified: November 2013

March 8, 2005
November 27, 2013
March 2005
October 2006   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00105157 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
  • Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies [ Time Frame: Baseline and Week 168 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.
  • Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies [ Time Frame: Baseline and Week 168 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.
Not Provided
 
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Drug: Comparator: MK0518
    MK0518 oral tablets 200 mg b.i.d, for 24 weeks
    Other Name: MK0518
  • Drug: MK0518
    MK0518 oral tablets 400 mg b.i.d, for 24 weeks
    Other Name: MK0518
  • Drug: MK0518
    MK0518 oral tablets 600 mg b.i.d, for 24 weeks
    Other Name: MK0518
  • Drug: Placebo
    Placebo to MK0518, oral tablet b.i.d, for 24 weeks
  • Experimental: 1
    MK0518 200 mg
    Intervention: Drug: Comparator: MK0518
  • Experimental: 2
    MK0518 400 mg
    Intervention: Drug: MK0518
  • Experimental: 3
    MK0518 600 mg
    Intervention: Drug: MK0518
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
July 2009
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00105157
0518-005, MK0518-005, 2005_007
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP