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

Study Overview
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Comparator: raltegravir


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>raltegravir | Drug: Comparator: raltegravir<br>* 400 mg tablets taken twice daily. Total treatment period is 48 weeks.<br>* Other names: ISENTRESS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point. | Week 48 | 
| Number of Participants With One or More Adverse Events | Numbers of participants with one or more adverse events were summarized by race. | Week 48 | 
| Number of Participants Who Discontinued Due to an Adverse Event | Numbers of participants who discontinued due to an adverse event were summarized by race. | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point. | Week 48 | 
| Mean Change From Baseline to Week 48 in HIV RNA | Mean changes from baseline in plasma HIV RNA were summarized by race at each time point. | Baseline and Week 48 | 
| Mean Change From Baseline to Week 48 in CD4 Cell Count | Mean changes from baseline in CD4 cell counts were summarized by race at each time point. | Baseline and Week 48 | 
| Number of Participants Without Loss of Virologic Response | For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). | Week 48 |