A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
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|ClinicalTrials.gov Identifier: NCT00764946|
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : April 12, 2012
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Comparator: raltegravir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2008|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
Drug: Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Other Name: ISENTRESS
- Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 48 ]Numbers of participants who discontinued due to an adverse event were summarized by race.
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 [ Time Frame: 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 [ Time Frame: Baseline and Week 48 ]Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
- Mean Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: 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 [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764946
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|