This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
179
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
Time frame: Baseline and Week 24
Number of Patients With Virologic Responses at Week 24
Number of patients who achieve HIV RNA \<400 copies/mL; HIV RNA level \<50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
Time frame: 24 weeks
Change From Baseline in CD4 Cell Count at Week 24
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Time frame: Baseline and Week 24
Number of Patients With Clinical Adverse Experiences (CAEs) at 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
Time frame: 48 weeks
Number of Patients With Serious CAEs at 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
Time frame: 48 weeks
Number of Patients With Drug-related CAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
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Placebo to MK0518, oral tablet b.i.d, for 24 weeks
Time frame: 48 weeks
Number of Patients With Serious Drug-related CAEs at 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 48 weeks
Number of Patients That Died by 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Serious CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 Drug-related LAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 48 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
Time frame: 48 weeks
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 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
Time frame: 96 weeks
Number of Patients With Serious CAEs at 96 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
Time frame: 96 weeks
Number of Patients With Drug-related CAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 96 weeks
Number of Patients With Serious Drug-related CAEs at 96 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 96 weeks
Number of Patients That Died by 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Serious CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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: 96 weeks
Number of Patients With Drug-related LAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 96 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
Time frame: 96 weeks
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 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
Time frame: 168 weeks
Number of Patients With Serious CAEs at 168 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
Time frame: 168 weeks
Number of Patients With Drug-related CAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 168 weeks
Number of Patients With Serious Drug-related CAEs at 168 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 168 weeks
Number of Patients That Died by 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Serious CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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: 168 weeks
Number of Patients With Serious LAEs at 168 Weeks
Serious LAEs are any LAEs 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: 168 weeks
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients With Drug-related LAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 168 weeks
Number of Patients With Serious Drug-related LAEs at 168 Weeks
Serious LAEs are any LAEs 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: 168 weeks
Number of Patients Discontinued With LAEs at 168 Weeks
Time frame: 168 weeks