Safety and Efficacy of an Investigational Drug in HIV-Infected Patients Failing Current Antiretroviral Therapies - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2005

Last Updated Date

August 19, 2009

Start Date ^ICMJE

March 2005

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

All accumulated safety data through Week 24; Change from baseline in HIV RNA levels at Week 24.

Change History

Complete list of historical versions of study NCT00105157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

At Week 24: proportion of patients with HIV RNA levels <400 and 50 copies/mL; change from baseline in CD4 cell count.

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of an Investigational Drug in HIV-Infected Patients Failing Current Antiretroviral Therapies

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections
Acquired Immunodeficiency Syndrome

Intervention ^ICMJE

Drug: Comparator: MK0518
Drug: Comparator: Placebo

Study Arms / Comparison Groups

Experimental: MK0518 200 mg
Experimental: MK0518 400 mg
Experimental: MK0518 600 mg
Placebo Comparator: Placebo

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00105157

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_007, MK0518-005

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

August 2009

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