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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Drug: Comparator: raltegravir Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
raltegravir
 Drug: Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Other Name: ISENTRESS


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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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