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

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT00764946
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-13
• Results First Submitted QC: 2012-03-16
• Results First Posted: 2012-04-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Week 48 in CD4 Cell Count	Baseline and Week 48	Mean changes from baseline in CD4 cell counts were summarized by race at each time point.
Number of Participants Without Loss of Virologic Response	Week 48	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).
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48	Week 48	Numbers of participants with HIV RNA copies \<400 copies/mL were summarized by race for each time point.
Mean Change From Baseline to Week 48 in HIV RNA	Baseline and Week 48	Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.