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

NCT00443703 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2017-03-21

Study results available
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Summary

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

Conditions

  • HIV Infection

Interventions

DRUG

MK0518 (raltegravir)

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

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.

DRUG

Comparator: placebo

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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-04-30
Completion
2009-04-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443703 on ClinicalTrials.gov