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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2011-05-31

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.

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

raltegravir potassium

Group Type EXPERIMENTAL

raltegravir potassium

Intervention Type DRUG

Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.

2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Interventions

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raltegravir potassium

Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.

Intervention Type DRUG

Comparator: placebo

Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Intervention Type DRUG

Other Intervention Names

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ISENTRESS™

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