A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

raltegravir

Group Type EXPERIMENTAL

Comparator: raltegravir

Intervention Type DRUG

400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Interventions

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Comparator: raltegravir

400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Intervention Type DRUG

Other Intervention Names

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ISENTRESS

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No