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A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

NCT00100048 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2015-09-09

Study results available
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Summary

This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Interventions

DRUG

Comparator: MK0518 monotherapy

MK0518 twice daily for 10 days

DRUG

Comparator: MK0518 combination therapy

MK0518 twice daily for 48 weeks

DRUG

Comparator: efavirenz

efavirenz 600 mg every night at bedtime for 48 weeks

DRUG

Comparator: tenofovir

tenofovir 300 mg daily for 48 weeks

DRUG

Comparator: lamivudine

lamivudine 300 mg daily for 48 weeks

DRUG

Placebo monotherapy

Placebo to MK0518 twice daily

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
2005-01-31
Primary Completion
2006-10-31
Completion
2010-07-31

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Entities

Companies

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 NCT00100048 on ClinicalTrials.gov