Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
- Conditions
- Acquired Immunodeficiency SyndromeHIV Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT00105157
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
- Patient must be currently on antiretroviral therapy (ART)
- Patient less than 18 years of age
- Additional exclusion criteria will be discussed and identified by the study doctor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 MK0518 MK0518 600 mg 4 Placebo Placebo 2 MK0518 MK0518 400 mg
- Primary Outcome Measures
Name Time Method Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 Baseline and Week 24 Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
- Secondary Outcome Measures
Name Time Method Number of Patients That Died by 48 Weeks 48 weeks Number of Patients That Discontinued With CAEs at 48 Weeks 48 weeks Change From Baseline in CD4 Cell Count at Week 24 Baseline and Week 24 Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks 48 weeks Number of Patients With Serious CAEs at 96 Weeks 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
Number of Patients With Serious Drug-related CAEs at 96 Weeks 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.
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks 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
Number of Patients With Drug-related LAEs at 168 Weeks 168 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients With Virologic Responses at Week 24 24 weeks 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
Number of Patients With Serious CAEs at 48 Weeks 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 That Discontinued With Serious CAEs at 48 Weeks 48 weeks Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks 48 weeks Number of Patients That Discontinued With Serious CAEs at 96 Weeks 96 weeks Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks 96 weeks Number of Patients With Drug-related CAEs at 168 Weeks 168 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients That Discontinued With Serious CAEs at 168 Weeks 168 weeks Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks 168 weeks Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks 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 Drug-related CAEs at 48 Weeks 48 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients With Serious Drug-related CAEs at 48 Weeks 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.
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks 48 weeks Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks 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
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks 48 weeks Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks 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
Number of Patients That Discontinued With CAEs at 168 Weeks 168 weeks Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks 168 weeks Number of Patients Discontinued With LAEs at 168 Weeks 168 weeks Number of Patients With Drug-related LAEs at 48 Weeks 48 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks 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
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks 96 weeks Number of Patients With Drug-related LAEs at 96 Weeks 96 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks 96 weeks Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks 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
Number of Patients With Serious Drug-related CAEs at 168 Weeks 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.
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks 168 weeks Number of Patients With Drug-related CAEs at 96 Weeks 96 weeks Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Number of Patients That Died by 96 Weeks 96 weeks Number of Patients That Discontinued With CAEs at 96 Weeks 96 weeks Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks 96 weeks Number of Patients With Serious CAEs at 168 Weeks 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
Number of Patients That Died by 168 Weeks 168 weeks Number of Patients With Serious LAEs at 168 Weeks 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
Number of Patients With Serious Drug-related LAEs at 168 Weeks 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