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Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)(COMPLETED)

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00377065
First received: September 14, 2006
Last updated: October 8, 2010
Last verified: October 2010
History of Changes
  Purpose

This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.


Condition Intervention
HIV Infections
 Drug: raltegravir

Study Type: Expanded Access     What is Expanded Access?
Official Title: Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Study Start Date: August 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: raltegravir
    raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks
    Other Names:
    • MK0518
    • ISENTRESS™
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive patients who have limited or no treatment options and have documented resistance

Exclusion Criteria:

  • Patient has previously been on MK0518 therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377065

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

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00377065     History of Changes
Other Study ID Numbers: 2006_031, MK0518-023
Study First Received: September 14, 2006
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013