A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019 EXT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00293254
First received: February 15, 2006
Last updated: August 30, 2013
Last verified: August 2013

February 15, 2006
August 30, 2013
February 2006
October 2007   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
  • Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
  • Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
  • Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
Proportion of patients achieving HIV RNA <400 copies/mL at Weeks 24; safety and tolerability assessed by review of the accumulated safety data.
Complete list of historical versions of study NCT00293254 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
  • Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
  • Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
  • Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
  • Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response [ Time Frame: 156 Weeks ] [ 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).
  • Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
  • Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
  • Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL) [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
  • Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL) [ Time Frame: Baseline and Week 240 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
  • Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3) [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
  • Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3) [ Time Frame: Baseline and Week 240 ] [ Designated as safety issue: No ]
    Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
At Week 24 and Week 48: (a) Proportion of patients with virologic response at week 24; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity at Week 48.
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019 EXT2)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.

The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV Infections
  • Drug: raltegravir potassium
    Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
    Other Name: ISENTRESS™
  • Drug: Comparator: placebo
    Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
  • Experimental: 1
    raltegravir potassium
    Intervention: Drug: raltegravir potassium
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Comparator: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
May 2011
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must be HIV positive with HIV RNA values that are within ranges required by the study
  • Patient must have documented failure of certain antiretroviral therapy
  • Patient must be on the same antiretroviral therapy for at least the past two months

Exclusion Criteria:

  • Patient less than 16 years old
  • Additional study criteria will be discussed and identified by the study doctor
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00293254
0518-019, 2005_097
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 2013

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