A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: raltegravir potassium
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>raltegravir potassium | Drug: raltegravir potassium<br>* Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.<br>* Other names: ISENTRESS™;|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: placebo<br>* Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 16 Weeks | 
| 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 | 48 Weeks | 
| 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 | 156 Weeks | 
| 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 | 240 Weeks | 
| 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). | 156 Weeks | 
| 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) | Baseline and Week 16 | 
| 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) | Baseline and Week 48 | 
| 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) | Baseline and Week 156 | 
| 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) | Baseline and Week 240 | 
| 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) | Baseline and Week 16 | 
| 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) | Baseline and Week 48 | 
| 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) | Baseline and Week 156 | 
| 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) | Baseline and Week 240 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced