Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy

This treatment has been approved for sale to the public.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00377065

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

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	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

Further study details as provided by Merck:

Study Start Date:

October 2006

Intervention Details:

raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks

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

Click here for more information about this study: "Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy" This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_031, MK0518-023
Study First Received:	September 14, 2006
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00377065
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009