A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
raltegravir potassium
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced
Eligibility 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 less than 16 years old Additional study criteria will be discussed and identified by the study doctor
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
raltegravir potassium
Placebo
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
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
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
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
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
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
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
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
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
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
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
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)
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)
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
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
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)
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)
Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
Full Information
NCT ID
NCT00293254
First Posted
February 15, 2006
Last Updated
February 14, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00293254
Brief Title
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
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 Antiretroviral Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
raltegravir potassium
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
raltegravir potassium
Other Intervention Name(s)
ISENTRESS™
Intervention Description
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Description
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
Time Frame
16 Weeks
Title
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Description
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
Time Frame
48 Weeks
Title
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Description
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
Time Frame
156 Weeks
Title
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Description
Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
Time Frame
240 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Description
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
Time Frame
16 Weeks
Title
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Description
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
Time Frame
48 Weeks
Title
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Description
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
Time Frame
156 Weeks
Title
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Description
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
Time Frame
240 Weeks
Title
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Description
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).
Time Frame
156 Weeks
Title
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Description
Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
Time Frame
Baseline and Week 16
Title
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Description
Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Time Frame
Baseline and Week 48
Title
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Description
Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Time Frame
Baseline and Week 156
Title
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Description
Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
Time Frame
Baseline and Week 240
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Description
Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
Time Frame
Baseline and Week 16
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Description
Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
Time Frame
Baseline and Week 48
Title
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Description
Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
Time Frame
Baseline and Week 156
Title
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Description
Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
Time Frame
Baseline and Week 240
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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 less than 16 years old
Additional study criteria will be discussed and identified by the study doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
18650512
Citation
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.
Results Reference
background
PubMed Identifier
18650513
Citation
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.
Results Reference
background
PubMed Identifier
20085491
Citation
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.
Results Reference
result
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
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