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

Phase 2

Completed

• Conditions: Acquired Immunodeficiency Syndrome; HIV Infections
• Interventions: Drug: Placebo monotherapy

• Registration Number: NCT00100048
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Study Timeline

• Study First Submitted: 2004-12-22
• Study First Submitted QC: 2004-12-22
• Study First Posted: 2004-12-23
• Study Start: 2005-01
• Primary Completion: 2006-10
• Results First Submitted: 2010-01-21
• Results First Submitted QC: 2010-03-25
• Results First Posted: 2010-03-29
• Study Completion: 2010-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo monotherapy	Placebo monotherapy	Placebo to MK0518 twice daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)	Week 24
Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)	Baseline and Day 10	Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Number of Patients With Serious CAEs (Cohort I and II Combined)	48 weeks	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)	10 days	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.; Serious CAEs are any AEs occurring at any dose that; Results; in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or; prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an; overdose.
Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)	Week 240	An AE was defined as any unfavorable \& unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.; A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.
Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240	Week 240	HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Number of Patients With Clinical Adverse Experiences (CAEs)	48 weeks	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144	144 Weeks	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product; An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)	Baseline and Week 24	Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)	Baseline and Week 24	Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)
Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)	Week 24
Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96	96 Weeks
Change From Baseline in CD4 (T-helper) Cell Count at Week 240	Baseline and Week 240	Change in number of CD4 cells/mm\^3 from baseline to Week 240.
Change From Baseline in Plasma HIV RNA at Week 96	Baseline and Week 96
Change From Baseline in CD4 Cell Count at Week 96	Baseline and Week 96
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240	Week 240	HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Change From Baseline in Plasma HIV RNA at Week 240	Baseline and Week 240	HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.