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| ID | Type | Description | Link |
|---|---|---|---|
| MK0518-005 | |||
| 2005_007 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0518 200 mg |
|
| 2 | Experimental | MK0518 400 mg |
|
| 3 | Experimental | MK0518 600 mg |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0518 | Drug | MK0518 oral tablets 200 mg b.i.d, for 24 weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases. | Baseline and Week 168 |
| Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17434401 | Background | Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2. |
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Patients failed prior antiretroviral therapy (HIV RNA >5000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.
Primary therapy period: 22-Apr-2005 to 09-Nov-2006
Multicenter (31) in the United States (15) and outside the United States (16)
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0518 200 mg b.i.d. | Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind (DB) |
|
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| MK0518 | Drug | MK0518 oral tablets 400 mg b.i.d, for 24 weeks |
|
| MK0518 | Drug | MK0518 oral tablets 600 mg b.i.d, for 24 weeks |
|
| Placebo | Drug | Placebo to MK0518, oral tablet b.i.d, for 24 weeks |
|
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 |
Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases. |
| Baseline and Week 168 |
| FG001 |
| MK0518 400 mg b.i.d. |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d. |
| FG002 | MK0518 600 mg b.i.d. | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| FG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Continuation of DB |
|
|
| Open-Label Post Virologic Failure(OLPVF) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK0518 200 mg b.i.d. | Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| BG001 | MK0518 400 mg b.i.d. | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d. |
| BG002 | MK0518 600 mg b.i.d. | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| BG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Cluster of Differentiation 4 (CD4) Cell Count | Mean | Full Range | Cells/mm3 |
| |||||||||||||||
| Plasma HIV RNA | Mean | Full Range | log10 copies/mL |
| |||||||||||||||
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) | Mean | Full Range | Copies/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy | Posted | Mean | 95% Confidence Interval | HIV RNA (log10 copies/mL) | Baseline and Week 24 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication and had HIV RNA tests performed were included in the analysis. | Posted | Number | Participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 24 | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) | Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | CD4 Cell Count (cells/mm3) | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients That Died by 48 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients That Discontinued With CAEs at 48 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients That Discontinued With Serious CAEs at 48 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 48 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | 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 | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | Number of Patients Discontinued With Drug-related LAEs at 48 Weeks | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 48 weeks |
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| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | 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 | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | 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. | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | Number of Patients That Died by 96 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | Number of Patients That Discontinued With CAEs at 96 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
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| Secondary | Number of Patients That Discontinued With Serious CAEs at 96 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 96 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | Participants | 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinued With Drug-related LAEs at 96 Weeks | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 96 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Patients With Virologic Responses at Week 168 in Combined Substudies | Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168. | Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies | Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases. | Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Mean | 95% Confidence Interval | HIV RNA (log10 copies/mL) | Baseline and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies | Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases. | Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Mean | 95% Confidence Interval | CD4 Cell Count (cells/mm3) | Baseline and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
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| Secondary | Number of Patients That Died by 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients That Discontinued With CAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients That Discontinued With Serious CAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinued With Drug-related LAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinued With LAEs at 168 Weeks | All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases. | Posted | Number | Participants | 168 weeks |
|
168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.
AEs were assessed by the investigators.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0518 | Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d. | 28 | 133 | 131 | 133 | ||
| EG001 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. | 3 | 45 | 39 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anogenital Dysplasia | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Varices Oesophageal | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Portal Hypertension | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anogenital Warts | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Leishmaniasis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Splenic Abscess | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Staphylococcal Abscess | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anal Cancer Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hodgkin's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Facial Palsy | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lacunar Infarction | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cardiovascular Disorder | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cerumen Impaction | Ear and labyrinth disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Ocular Icterus | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anogenital Dysplasia | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gastric Disorder | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Drug Intolerance | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Injection Site Inflammation | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Injection Site Nodule | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sensation Of Pressure | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Acute Tonsillitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anogenital Warts | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Genital Herpes | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Herpes Virus Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Papilloma Viral Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sinusitis Bacterial | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Amylase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Cholesterol Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Phosphorus Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Potassium Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Testosterone Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Blood Urine Present | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Low Density Lipoprotein Increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Protein Urine Present | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Muscle Hypertrophy | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dysphasia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Facial Palsy | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hemicephalalgia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Renal Cyst | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Facial Wasting | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lipodystrophy Acquired | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Skin Nodule | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Subcutaneous Nodule | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
Due to a 3:1 randomization of MK-0518 to placebo and more discontinuations for placebo in the doubleblind phase, exposure for MK-0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Patient did not continue in extension |
|
| Patient moved/site stopped trial |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Patient moved/Site stopped trial |
|
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
|
| Others |
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 |
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| OG003 | Placebo | OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|
| Placebo |
OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy. |
|
|