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A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

NCT00369941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2017-03-21

Study results available
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Summary

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Conditions

  • HIV Infections

Interventions

DRUG

MK-0518

400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks

DRUG

Comparator: efavirenz

600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks

DRUG

Comparator: Truvada

One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)

DRUG

Comparator: Placebo to MK-0518

Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks

DRUG

Comparator: Placebo to efavirenz

Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks

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
2006-08-31
Primary Completion
2009-05-31
Completion
2012-02-29

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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 NCT00369941 on ClinicalTrials.gov