A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00100048
First received: December 22, 2004
Last updated: October 23, 2013
Last verified: October 2013

December 22, 2004
October 23, 2013
January 2005
October 2006   (final data collection date for primary outcome measure)
  • Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: No ]
    Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
  • Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) [ Time Frame: 10 days ] [ 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.

    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 Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of Patients With Clinical Adverse Experiences (CAEs) [ 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 (Cohort I and II Combined) [ 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 Serious CAEs and Non-serious CAEs at Week 144 [ Time Frame: 144 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

    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 Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) [ Time Frame: Week 240 ] [ Designated as safety issue: Yes ]

    An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.

    A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.

  • Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 [ Time Frame: Week 240 ] [ Designated as safety issue: No ]
    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Not Provided
Complete list of historical versions of study NCT00100048 on ClinicalTrials.gov Archive Site
  • Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)
  • Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) [ 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 HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Plasma HIV RNA at Week 96 [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
  • Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 [ Time Frame: Week 240 ] [ Designated as safety issue: No ]
    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
  • Change From Baseline in Plasma HIV RNA at Week 240 [ Time Frame: Baseline and Week 240 ] [ Designated as safety issue: No ]
    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
  • Change From Baseline in CD4 (T-helper) Cell Count at Week 240 [ Time Frame: Baseline and Week 240 ] [ Designated as safety issue: No ]
    Change in number of CD4 cells/mm^3 from baseline to Week 240.
Not Provided
  • Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of Patients With Drug-related CAEs [ 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 [ 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 Discontinued With CAEs [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With Laboratory Adverse Experiences (LAEs) [ 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 Serious LAEs [ Time Frame: 48 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 With Drug-related LAEs [ 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 With Serious Drug-related LAEs [ Time Frame: 48 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 That Discontinued With LAEs [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
 
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients

This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.

Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

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 monotherapy
    MK0518 twice daily for 10 days
  • Drug: Comparator: MK0518 combination therapy
    MK0518 twice daily for 48 weeks
  • Drug: Comparator: efavirenz
    efavirenz 600 mg every night at bedtime for 48 weeks
  • Drug: Comparator: tenofovir
    tenofovir 300 mg daily for 48 weeks
  • Drug: Comparator: lamivudine
    lamivudine 300 mg daily for 48 weeks
  • Drug: Placebo monotherapy
    Placebo to MK0518 twice daily
  • Experimental: 600 mg monotherapy
    MK0518 600 mg twice daily
    Intervention: Drug: Comparator: MK0518 monotherapy
  • Experimental: 400 mg monotherapy
    MK0518 400 mg twice daily
    Intervention: Drug: Comparator: MK0518 monotherapy
  • Experimental: 200 mg monotherapy
    MK0518 200 mg twice daily
    Intervention: Drug: Comparator: MK0518 monotherapy
  • Experimental: 100 mg monotherapy
    MK0518 100 mg twice daily
    Intervention: Drug: Comparator: MK0518 monotherapy
  • Placebo Comparator: placebo monotherapy
    Placebo to MK0518 twice daily
    Intervention: Drug: Placebo monotherapy
  • Experimental: 600 mg combo therapy
    MK0518 600 mg + tenofovir + lamivudine
    Interventions:
    • Drug: Comparator: MK0518 combination therapy
    • Drug: Comparator: tenofovir
    • Drug: Comparator: lamivudine
  • Experimental: 400 mg combo therapy
    MK0518 400 mg + tenofovir + lamivudine
    Interventions:
    • Drug: Comparator: MK0518 combination therapy
    • Drug: Comparator: tenofovir
    • Drug: Comparator: lamivudine
  • Experimental: 200 mg combo therapy
    MK0518 200 mg + tenofovir + lamivudine
    Interventions:
    • Drug: Comparator: MK0518 combination therapy
    • Drug: Comparator: tenofovir
    • Drug: Comparator: lamivudine
  • Experimental: 100 mg combo therapy
    MK0518 100 mg + tenofovir + lamivudine
    Interventions:
    • Drug: Comparator: MK0518 combination therapy
    • Drug: Comparator: tenofovir
    • Drug: Comparator: lamivudine
  • Active Comparator: EFV combo therapy
    efavirenz + tenofovir + lamivudine
    Interventions:
    • Drug: Comparator: efavirenz
    • Drug: Comparator: tenofovir
    • Drug: Comparator: lamivudine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
July 2010
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)

Extension Studies:

  • First extension: Patient completed the 48-week base study
  • Second extension: Patient completed the first 144-week extension study

Exclusion Criteria:

  • Less than 18 years of age
  • Individuals who currently do not test positive for HIV
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00100048
0518-004, 2004_096
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

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