Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Drug: Comparator: MK0518
* Drug: MK0518
* Drug: MK0518
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Patient less than 18 years of age Additional exclusion criteria will be discussed and identified by the study doctor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0518 200 mg | Drug: Comparator: MK0518<br>* MK0518 oral tablets 200 mg b.i.d, for 24 weeks<br>* Other names: MK0518;|
| Experimental: 2<br>MK0518 400 mg | Drug: MK0518<br>* MK0518 oral tablets 400 mg b.i.d, for 24 weeks<br>|
| Experimental: 3<br>MK0518 600 mg | Drug: MK0518<br>* MK0518 oral tablets 600 mg b.i.d, for 24 weeks<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Placebo to MK0518, oral tablet b.i.d, for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 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 | 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. | 48 weeks | 
| Number of Patients That Died by 48 Weeks |  | 48 weeks | 
| Number of Patients That Discontinued With CAEs at 48 Weeks |  | 48 weeks | 
| Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks |  | 48 weeks | 
| 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 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 | 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 | 48 weeks | 
| Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks |  | 48 weeks | 
| Number of Patients Discontinued With Drug-related LAEs at 48 Weeks |  | 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 | 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 | 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 | 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. | 96 weeks | 
| 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 That Discontinued With Serious CAEs at 96 Weeks |  | 96 weeks | 
| Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks |  | 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 | 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 | 96 weeks | 
| Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks |  | 96 weeks | 
| Number of Patients Discontinued With Drug-related LAEs at 96 Weeks |  | 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 | 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 | 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 | 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. | 168 weeks | 
| Number of Patients That Died by 168 Weeks |  | 168 weeks | 
| 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 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 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 | 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 | 168 weeks | 
| Number of Patients Discontinued With Drug-related LAEs at 168 Weeks |  | 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 | 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 | 168 weeks | 
| Number of Patients Discontinued With LAEs at 168 Weeks |  | 168 weeks |