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

NCT00293254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2017-03-21

Study results available
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Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

raltegravir potassium

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

DRUG

Comparator: placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-10-31
Completion
2011-05-31

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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 NCT00293254 on ClinicalTrials.gov