MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.

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Detailed Description

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Conditions

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HIV Infection

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

Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )

Group Type EXPERIMENTAL

MK0518 (raltegravir)

Intervention Type DRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment

Comparator: placebo

Intervention Type DRUG

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.

2

Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)

Group Type ACTIVE_COMPARATOR

Comparator: KALETRA™ (lopinavir (+) ritonavir )

Intervention Type DRUG

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.

Comparator: placebo

Intervention Type DRUG

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

Interventions

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MK0518 (raltegravir)

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment

Intervention Type DRUG

Comparator: KALETRA™ (lopinavir (+) ritonavir )

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.

Intervention Type DRUG

Comparator: placebo

MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

Intervention Type DRUG

Comparator: placebo

KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.

Intervention Type DRUG

Other Intervention Names

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MK0518 raltegravir KALETRA

Eligibility Criteria

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Inclusion Criteria

* Patient is at least 18 years of age
* Patient is Human Immunodeficiency Virus (HIV) positive
* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
* Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen

Exclusion Criteria

* Patient is or plans to become pregnant, or nursing a child
* Patient plans to donate eggs or impregnate/donate sperm
* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
* Patient is currently receiving a second protease inhibitor in addition to KALETRA
* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
* Patient has used another experimental HIV-integrase inhibitor
* Patient has a current (active) diagnosis of acute hepatitis due to any cause
* Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No