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)

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-092-06

Enrollment

Registered

2007-01-10

Start date

2007-02-19

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group

This group will be treated with MK-0518 in a dose of 400 mg, BID, PO + Efavirenz Placebo, QHD, PO, both in a TRUVADA ™ tablet (in fixed dose in combination with 200 mg of Emtricitabine + 300 mg of Tenofovir) for 96 weeks. Group name:GROUP 2 Type of group

This group will be treated with MK-0518 Placebo, IDB, PO + Efavirenz in a dose of 600 mg, QHD, PO, both in a TRUVADA ™ tablet (in fixed dose in combination with 200 mg of Emtricitabine + 300 mg of Tenofovir) for 96 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1) Participant is a male or female at least 18 years of age. 2) Participant is HIV positive. 3) Participant is naive to antiretroviral therapy (ART) and has not received any ART.

Exclusion criteria

Exclusion criteria: 1) Participant has received approved or experimental antiretroviral agents in the past. 2) Participant has been treated for a viral infection other than HIV. 3) Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz. 4) Participant has used another experimental HIV-integrase inhibitor. 5) Participant has a current (active) diagnosis of acute hepatitis. 6) Participants with chronic hepatitis.

Design outcomes

Primary

Measure	Time frame
Outcome name:Peripheral blood measurement of HIV RNA levels. Measure:Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL. Timepoints:Week 48-. ; Outcome name:Clinical evaluation to determine the adverse events and the severity of these. Laboratory panels for hematology and serum biochemistry, urine tests. Measure:Safety of treatment: 1) Number of Participants With Clinical Adverse Experiences. 2) Number of Participants With Serious CAEs. 3) Number of Participants That Died. 4) Number of Participants That Discontinued With CAEs. 5) Number of Participants That Discontinued With Serious CAEs. 6) Number of Participants That Discontinued With Drug-related CAEs. 7) Number of Participants That Discontinued With Serious Drug-related CAEs. 8) Number of Participants With Laboratory Adverse Experiences (LAE). 9) Number of Participants With Serious LAE. 10) Number of Participants With Serious Drug-related LAE. 11) Number of Participants Discontinued With LAEs. 12) Number of Participants Discontinued With Drug-related LAEs. Timepoints:Week 48.	—

Measure

Time frame

Outcome name:Peripheral blood measurement of HIV RNA levels. Measure:Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL. Timepoints:Week 48-. ; Outcome name:Clinical evaluation to determine the adverse events and the severity of these. Laboratory panels for hematology and serum biochemistry, urine tests. Measure:Safety of treatment: 1) Number of Participants With Clinical Adverse Experiences. 2) Number of Participants With Serious CAEs. 3) Number of Participants That Died. 4) Number of Participants That Discontinued With CAEs. 5) Number of Participants That Discontinued With Serious CAEs. 6) Number of Participants That Discontinued With Drug-related CAEs. 7) Number of Participants That Discontinued With Serious Drug-related CAEs. 8) Number of Participants With Laboratory Adverse Experiences (LAE). 9) Number of Participants With Serious LAE. 10) Number of Participants With Serious Drug-related LAE. 11) Number of Participants Discontinued With LAEs. 12) Number of Participants Discontinued With Drug-related LAEs. Timepoints:Week 48.

—

Secondary

Measure	Time frame
Outcome name:Peripheral blood measurement of HIV RNA levels. Flow cytometry to determine CD4 LT levels. Measure:Secondary Efficacy: 1) Number of Participants Who Achieved HIV RNA <400 Copies/mL. 2) Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count. 3) Number of Participants Who Achieved HIV RNA <50 Copies/mL. Timepoints:Weeks 48, 96, 156, 240.	—

Countries

Australia, Brazil, Canada, Chile, Colombia, France, Germany, India, Italy, Mexico, Spain, Thailand, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results