A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: raltegravir potassium

• Registration Number: NCT00293267
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-17
• Primary Completion: 2007-08
• Results First Submitted: 2009-08-18
• Results First Submitted QC: 2009-09-25
• Results First Posted: 2009-09-28
• Study Completion: 2011-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	raltegravir potassium	raltegravir potassium

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16	16 Weeks	Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL	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	240 Weeks	Percentage of participants who achieved HIV RNA \<400 Copies/mL at Week 240
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48	48 Weeks	Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 48

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16	Baseline and Week 16	Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48	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	156 weeks	Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 156
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)	Baseline and Week 156	Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16	Baseline and Week 16	Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm\^3)
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL	240 weeks	Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 240
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16	16 Weeks	Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 16
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response	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 48	Baseline and Week 48	Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)	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 48	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)	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)	Baseline and Week 240	Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm\^3)