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A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00764946
First received: October 1, 2008
Last updated: February 14, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Human Immunodeficiency Virus | Drug: Comparator: raltegravir | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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).
| Enrollment: | 209 |
| Study Start Date: | October 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
raltegravir
|
Drug: Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Other Name: ISENTRESS
|
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764946
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764946
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00764946 History of Changes |
| Other Study ID Numbers: |
0518-055 2008_555 |
| Study First Received: | October 1, 2008 |
| Results First Received: | February 13, 2012 |
| Last Updated: | February 14, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 18, 2017