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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:
ClinicalTrials.gov Identifier:
NCT00293267
First Posted: February 17, 2006
Last Update Posted: September 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00293267


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

Publications:
Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.
Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00293267     History of Changes
Other Study ID Numbers: 0518-018
2005_096
First Submitted: February 14, 2006
First Posted: February 17, 2006
Results First Submitted: August 18, 2009
Results First Posted: September 28, 2009
Last Update Posted: September 7, 2015
Last Verified: September 2015

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

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


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