A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00764946

Purpose

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with HIV, where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.

Condition	Intervention	Phase
Human Immunodeficiency Virus	Drug: Comparator: raltegravir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients

Further study details as provided by Merck:

Primary Outcome Measures:

safety and tolerability of raltegravir and proportion of patients achieving HIV RNA < 50 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the antiretroviral activity of raltegravir in combination with other antiretroviral agents. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental raltegravir	Drug: Comparator: raltegravir 400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patient is HIV positive
Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Exclusion Criteria:

If female, pregnant or breastfeeding
Patient has used an investigational agent in the last 30 days
Patient has acute hepatitis
Patient has received MK0518 (raltegravir) before
Patient has used another experimental HIV-integrase inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764946

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arizona
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Phoenix, Arizona, United States, 85006
United States, California
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Torrance, California, United States, 90502
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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West Palm Beach, Florida, United States, 33401
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Orlando, Florida, United States, 32803
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Miami, Florida, United States, 33137
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Hialeah, Florida, United States, 33012
United States, Georgia
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Savannah, Georgia, United States, 31410
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Atlanta, Georgia, United States, 30308-1923
United States, Illinois
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Chicago, Illinois, United States, 60612
United States, Maryland
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Baltimore, Maryland, United States, 21201-0000
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Baltimore, Maryland, United States, 21201
United States, Massachusetts
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Boston, Massachusetts, United States, 02115-0000
United States, Missouri
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St. Louis, Missouri, United States, 63108
United States, New Jersey
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Newark, New Jersey, United States, 07103
United States, New York
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Rochester, New York, United States, 14604
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Albany, New York, United States, 12208
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
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Columbia, South Carolina, United States, 29203
United States, Texas
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Houston, Texas, United States, 77004

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_555, MK0518-055
Study First Received:	October 1, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00764946
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

ClinicalTrials.gov processed this record on January 13, 2009