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

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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

NCT00100048•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)
•Extension Studies:
•First extension: Patient completed the 48-week base study
•Second extension: Patient completed the first 144-week extension study

Exclusion Criteria

•Less than 18 years of age
•Individuals who currently do not test positive for HIV

Key Dates

Start Date

January 1, 2005

Primary Completion Date

October 1, 2006

Completion Date

July 1, 2010

Last Updated

September 9, 2015

Enrollment

206

ACTUAL participants

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Comparator: MK0518 monotherapy

DRUG

Comparator: MK0518 combination therapy

DRUG

Comparator: efavirenz

DRUG

Comparator: tenofovir

DRUG

Comparator: lamivudine

DRUG

Placebo monotherapy

DRUG

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HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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