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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Drug: Comparator: raltegravir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 209 participants |
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 |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
raltegravir
|
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).

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764946
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications of Results:
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00764946 History of Changes |
Other Study ID Numbers: |
0518-055 2008_555 |
First Posted: | October 2, 2008 Key Record Dates |
Results First Posted: | April 12, 2012 |
Last Update Posted: | March 21, 2017 |
Last Verified: | February 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 |