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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00764946
First received: October 1, 2008
Last updated: August 1, 2014
Last verified: August 2014

October 1, 2008
August 1, 2014
October 2008
February 2011   (final data collection date for primary outcome measure)
  • 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.
safety and tolerability of raltegravir and proportion of patients achieving HIV RNA < 50 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00764946 on ClinicalTrials.gov Archive Site
  • 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).
Evaluate the antiretroviral activity of raltegravir in combination with other antiretroviral agents. [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Other Name: ISENTRESS
Experimental: 1
raltegravir
Intervention: Drug: Comparator: raltegravir
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00764946
0518-055, 2008_555
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP