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A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00764946
First received: October 1, 2008
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764946

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00764946     History of Changes
Other Study ID Numbers: MK-0518-055, 2008_555
Study First Received: October 1, 2008
Results First Received: February 13, 2012
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013