Full Text View
Tabular View
Study Results
Related Studies
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-018)
This study has been completed.

First Received on February 14, 2006.   Last Updated on May 5, 2011   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00293267
  Purpose

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


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

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 MK0518 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency
MedlinePlus related topics: HIV/AIDS Potassium
Drug Information available for: Raltegravir Raltegravir potassium Potassium chloride
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Proportion of patients who achieve HIV RNA <400 copies/mL at Week 16


Secondary Outcome Measures:
  • Change From Baseline in HIV RNA 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 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)

  • Change From Baseline in CD4 Cell Count 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 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)


Enrollment: 352
Study Start Date: February 2006
Study Completion Date: April 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 b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
Other Name: ISENTRESS
Placebo Comparator: 2
Placebo
 Drug: Comparator: Placebo
Placebo bid p.o. with optimized background therapy. Treatment period of 48 weeks.

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

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

Publications:
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.
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.

Responsible Party: Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00293267     History of Changes
Other Study ID Numbers: 2005_096, MK0518-018
Study First Received: February 14, 2006
Results First Received: August 18, 2009
Last Updated: May 5, 2011
Health Authority: France: Ministry of Health

Keywords provided by Merck:
Treatment Experienced

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

ClinicalTrials.gov processed this record on February 12, 2012



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services