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A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00293267
First received: February 14, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: raltegravir potassium
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 Antiviral Therapies

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 (log10 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 (log10 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)


Enrollment: 352
Study Start Date: February 2006
Study Completion Date: May 2011
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
raltegravir potassium
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™
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 is less than 16 years old
  • Additional study criteria will be discussed and identified by the study doctor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293267

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00293267     History of Changes
Other Study ID Numbers: 0518-018, 2005_096
Study First Received: February 14, 2006
Results First Received: August 18, 2009
Last Updated: September 26, 2014
Health Authority: France: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
Treatment Experienced

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

ClinicalTrials.gov processed this record on November 25, 2014