Back to resultsA Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: raltegravir
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
raltegravir
Outcomes
Primary Outcome Measures
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.
Number of Participants With One or More Adverse Events
Numbers of participants with one or more adverse events were summarized by race.
Number of Participants Who Discontinued Due to an Adverse Event
Numbers of participants who discontinued due to an adverse event were summarized by race.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT00764946
First Posted
October 1, 2008
Last Updated
February 14, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00764946
Brief Title
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
raltegravir
Intervention Type
Drug
Intervention Name(s)
Comparator: raltegravir
Other Intervention Name(s)
ISENTRESS
Intervention Description
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Description
Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.
Time Frame
Week 48
Title
Number of Participants With One or More Adverse Events
Description
Numbers of participants with one or more adverse events were summarized by race.
Time Frame
Week 48
Title
Number of Participants Who Discontinued Due to an Adverse Event
Description
Numbers of participants who discontinued due to an adverse event were summarized by race.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Description
Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.
Time Frame
Week 48
Title
Mean Change From Baseline to Week 48 in HIV RNA
Description
Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
Time Frame
Baseline and Week 48
Title
Mean Change From Baseline to Week 48 in CD4 Cell Count
Description
Mean changes from baseline in CD4 cell counts were summarized by race at each time point.
Time Frame
Baseline and Week 48
Title
Number of Participants Without Loss of Virologic Response
Description
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).
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
23351187
Citation
Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26.
Results Reference
result
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A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
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