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Safety and Efficacy of an Investigational Drug in HIV-Infected Patients Failing Current Antiretroviral Therapies
This study has been completed.
First Received: March 8, 2005   Last Updated: August 19, 2009   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: Comparator: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:


Further study details as provided by Merck:

Primary Outcome Measures:
  • Change from baseline in plasma HIV RNA (log10 copies/mL) at Week 24 in Combined Substudies [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients With Virologic Responses at Week 24 in Combined Substudies [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 Cell Count at Week 24 in Combined Substudies [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients with clinical adverse experiences (CAEs) at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with serious CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with drug-related CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with serious drug-related CAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Number of patients with drug-related LAEs at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Number of patients with serious CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with drug-related CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with serious drug-related CAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Number of patients with drug-related LAEs at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]

Enrollment: 200
Study Start Date: March 2005
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
MK0518 200 mg
Drug: Comparator: MK0518
MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
2: Experimental
MK0518 400 mg
Drug: Comparator: MK0518
MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
3: Experimental
MK0518 600 mg
Drug: Comparator: MK0518
MK0518 oral tablets 200, 400 or 600 mg b.i.d, for 24 weeks
4: Placebo Comparator
Placebo
Drug: Comparator: 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 HIV 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:
Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_007, MK0518-005
Study First Received: March 8, 2005
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00105157     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 05, 2009