This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
MK0518 twice daily for 10 days
MK0518 twice daily for 48 weeks
efavirenz 600 mg every night at bedtime for 48 weeks
Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Time frame: Baseline and Day 10
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
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.
Time frame: 10 days
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
Time frame: Week 24
Number of Patients With Clinical Adverse Experiences (CAEs)
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.
Time frame: 48 weeks
Number of Patients With Serious CAEs (Cohort I and II Combined)
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
Time frame: 48 weeks
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
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tenofovir 300 mg daily for 48 weeks
lamivudine 300 mg daily for 48 weeks
Placebo to MK0518 twice daily
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
Time frame: 144 Weeks
Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
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.
Time frame: Week 240
Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Time frame: Week 240
Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
Time frame: Week 24
Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)
Time frame: Baseline and Week 24
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Time frame: Baseline and Week 24
Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
Time frame: 96 Weeks
Change From Baseline in Plasma HIV RNA at Week 96
Time frame: Baseline and Week 96
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline and Week 96
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Time frame: Week 240
Change From Baseline in Plasma HIV RNA at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Time frame: Baseline and Week 240
Change From Baseline in CD4 (T-helper) Cell Count at Week 240
Change in number of CD4 cells/mm\^3 from baseline to Week 240.
Time frame: Baseline and Week 240