Clinical trial NCT00293254: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 351
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
timeFrame: 16 Weeks
measure: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
timeFrame: 48 Weeks
measure: Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
timeFrame: 156 Weeks
measure: Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
timeFrame: 240 Weeks
Secondary outcomes:
measure: Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
timeFrame: 16 Weeks
measure: Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
timeFrame: 48 Weeks
measure: Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
timeFrame: 156 Weeks
measure: Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
timeFrame: 240 Weeks
measure: Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
timeFrame: 156 Weeks
measure: Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
timeFrame: Baseline and Week 48
measure: Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
timeFrame: Baseline and Week 156
measure: Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
timeFrame: Baseline and Week 240
measure: Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
timeFrame: Baseline and Week 48
measure: Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
timeFrame: Baseline and Week 156
measure: Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
timeFrame: Baseline and Week 240
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.
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.
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.