A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 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 Antiviral Therapies
2 other identifiers
interventional
352
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Feb 2006
Longer than P75 for phase_3 hiv-infections
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 14, 2006
CompletedFirst Posted
Study publicly available on registry
February 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedResults Posted
Study results publicly available
September 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedSeptember 7, 2015
September 1, 2015
1.5 years
February 14, 2006
August 18, 2009
September 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
16 Weeks
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
48 Weeks
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
156 Weeks
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
240 Weeks
Secondary Outcomes (13)
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
16 Weeks
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
48 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
156 weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
240 weeks
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
156 weeks
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALraltegravir potassium
2
PLACEBO COMPARATORPlacebo
Interventions
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient is less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 18650512BACKGROUNDCooper 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.
PMID: 18650513BACKGROUNDSteigbigel 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.
PMID: 20085491RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2006
First Posted
February 17, 2006
Study Start
February 1, 2006
Primary Completion
August 1, 2007
Study Completion
May 1, 2011
Last Updated
September 7, 2015
Results First Posted
September 28, 2009
Record last verified: 2015-09