NCT00100048

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

Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily. Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

Conditions

• HIV Infections
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-10-01
• Completion: 2010-07-01
• First posted: 2004-12-23
• Last updated: 2015-09-09
• Results posted: 2010-03-29