Acquired Immunodeficiency Syndrome, HIV Infections
Conditions
Brief summary
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
Detailed description
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily. Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.
Interventions
DRUGComparator: MK0518 monotherapy
MK0518 twice daily for 10 days
DRUGComparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
efavirenz 600 mg every night at bedtime for 48 weeks
DRUGComparator: tenofovir
tenofovir 300 mg daily for 48 weeks
DRUGComparator: lamivudine
lamivudine 300 mg daily for 48 weeks
Placebo to MK0518 twice daily
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy) Extension Studies: * First extension: Patient completed the 48-week base study * Second extension: Patient completed the first 144-week extension study
Exclusion criteria
* Less than 18 years of age * Individuals who currently do not test positive for HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | Baseline and Day 10 | Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) |
| Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 | Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. |
| Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | Week 240 | An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose. |
| Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | 144 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 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 CAEs (Cohort I and II Combined) | 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 With Clinical Adverse Experiences (CAEs) | 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 Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | Week 24 | — |
| Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | 10 days | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma HIV RNA at Week 96 | Baseline and Week 96 | — |
| Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | Week 24 | — |
| Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | Baseline and Week 24 | Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) |
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | Baseline and Week 24 | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) |
| Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | 96 Weeks | — |
| Change From Baseline in CD4 Cell Count at Week 96 | Baseline and Week 96 | — |
| Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 | Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. |
| Change From Baseline in Plasma HIV RNA at Week 240 | Baseline and Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. |
| Change From Baseline in CD4 (T-helper) Cell Count at Week 240 | Baseline and Week 240 | Change in number of CD4 cells/mm\^3 from baseline to Week 240. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Drug-related CAEs | 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 That Discontinued With LAEs | 48 Weeks | — |
| Number of Patients With Serious Drug-related LAEs | 48 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 Drug-related LAEs | 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 Serious LAEs | 48 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 Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 48 weeks | — |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | 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 That Discontinued With CAEs | 48 Weeks | — |
| Number of Patients With Serious Drug-related CAEs | 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. |
Participant flow
Recruitment details
Primary therapy period: For Part I (10 day monotherapy): 24-Jan-2005 to 04-May-2005 Part II (Dose Ranging): 14-Jun-2005 to 04-Oct-2006 (48 weeks); 14-Jun-2005 to 12-Jul-2010 (240 weeks) Multicenter (29) in the United States (14) and Ex-US (15)
Pre-assignment details
Patients with Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) of at least 5000 copies/mL and cluster of differentiation 4 (CD4) cell counts of at least 100 cells/mm3. All patients must have met laboratory criteria. 206 enrolled; 5 from Cohort I did not continue to the combination phase. Therefore 201 entered the combination phase.
Participants by arm
| Arm | Count |
|---|---|
| MK0518 100 mg b.i.d. Cohort I-Monotherapy Phase (10 Days)
MK0518 100 mg twice daily (b.i.d.)
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d | 41 |
| MK0518 200 mg b.i.d Cohort I-Monotherapy Phase (10 Days)
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine | 40 |
| MK0518 400 mg b.i.d. Cohort I-Monotherapy Phase (10 Days)
MK0518 400 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine | 41 |
| MK0518 600 mg b.i.d. Cohort I-Monotherapy Phase (10 Days)
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine | 42 |
| Placebo / Efavirenz 600 mg Once Daily (q.d.) Cohort I-Monotherapy Phase (10 Days)
Placebo to MK0518 b.i.d.
Cohort II Combined-Combination Therapy Phase (48 Weeks)
Efavirenz + Tenofovir + Lamivudine | 42 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Cohort I & II-Combination Therapy Phase | Adverse Event | 0 | 1 | 2 | 0 | 0 | 1 |
| Cohort I & II-Combination Therapy Phase | Completed Base Study, Did Not Continue | 1 | 1 | 2 | 0 | 0 | 2 |
| Cohort I & II-Combination Therapy Phase | Laboratory Adverse Experience | 0 | 0 | 0 | 1 | 0 | 0 |
| Cohort I & II-Combination Therapy Phase | Lack of Efficacy | 1 | 3 | 0 | 0 | 0 | 2 |
| Cohort I & II-Combination Therapy Phase | Lost to Follow-up | 2 | 1 | 3 | 2 | 0 | 3 |
| Cohort I & II-Combination Therapy Phase | Never Treated | 2 | 0 | 0 | 0 | 0 | 1 |
| Cohort I & II-Combination Therapy Phase | Other Reason | 7 | 1 | 4 | 2 | 0 | 0 |
| Cohort I & II-Combination Therapy Phase | Withdrawal by Subject | 1 | 2 | 2 | 5 | 0 | 4 |
Baseline characteristics
| Characteristic | MK0518 200 mg b.i.d | MK0518 100 mg b.i.d. | MK0518 400 mg b.i.d. | MK0518 600 mg b.i.d. | Placebo / Efavirenz 600 mg Once Daily (q.d.) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous Cohort I | 37 Years | 46 Years | 41 Years | 39 Years | 36 Years | 40 Years |
| Age, Continuous Cohort II | 31 Years | 34 Years | 34 Years | 36 Years | 36 Years | 35 Years |
| Age, Continuous Cohort I & II Combined | 34 Years | 37 Years | 36 Years | 37 Years | 36 Years | 36 Years |
| Cluster of differentiation 4 (CD4) Cell Count Cohort I | 343 cells/mm^3 | 415 cells/mm^3 | 256 cells/mm^3 | 569 cells/mm^3 | 343 cells/mm^3 | 394 cells/mm^3 |
| Cluster of differentiation 4 (CD4) Cell Count Cohort I and II Combined | 277 cells/mm^3 | 272 cells/mm^3 | 293 cells/mm^3 | 244 cells/mm^3 | 225 cells/mm^3 | 266 cells/mm^3 |
| Cluster of differentiation 4 (CD4) Cell Count Cohort II | 292 cells/mm^3 | 293 cells/mm^3 | 348 cells/mm^3 | 245 cells/mm^3 | 276 cells/mm^3 | 291 cells/mm^3 |
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Cohort I | 34143 copies/mL | 44989 copies/mL | 37728 copies/mL | 93911 copies/mL | 58412 copies/mL | 51496 copies/mL |
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Cohort I and II Combined | 64715 copies/mL | 58206 copies/mL | 43083 copies/mL | 57919 copies/mL | 67554 copies/mL | 57437 copies/mL |
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Cohort II | 73646 copies/mL | 65982 copies/mL | 47019 copies/mL | 61929 copies/mL | 76752 copies/mL | 63965 copies/mL |
| Race/Ethnicity, Customized Asian (Cohort I) | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian (Cohort II) | 6 participants | 3 participants | 8 participants | 7 participants | 8 participants | 32 participants |
| Race/Ethnicity, Customized Black (Cohort I) | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black (Cohort II) | 1 participants | 1 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic (Cohort I) | 2 participants | 2 participants | 3 participants | 0 participants | 3 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic (Cohort II) | 9 participants | 12 participants | 10 participants | 9 participants | 10 participants | 50 participants |
| Race/Ethnicity, Customized Never Treated (Cohort II) | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Other (Cohort II) | 7 participants | 13 participants | 5 participants | 10 participants | 6 participants | 41 participants |
| Race/Ethnicity, Customized White (Cohort I) | 4 participants | 4 participants | 3 participants | 8 participants | 3 participants | 22 participants |
| Race/Ethnicity, Customized White (Cohort II) | 10 participants | 4 participants | 11 participants | 8 participants | 10 participants | 43 participants |
| Sex/Gender, Customized Female (Cohort I) | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Sex/Gender, Customized Female (Cohort II) | 10 participants | 6 participants | 4 participants | 11 participants | 8 participants | 39 participants |
| Sex/Gender, Customized Male (Cohort I) | 6 participants | 7 participants | 6 participants | 8 participants | 6 participants | 33 participants |
| Sex/Gender, Customized Male (Cohort II) | 23 participants | 27 participants | 31 participants | 23 participants | 26 participants | 130 participants |
| Sex/Gender, Customized Never Treated Cohort II | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 147 / 160 | 35 / 38 |
| serious Total, serious adverse events | 25 / 160 | 4 / 38 |
Outcome results
Primary
Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Time frame: Baseline and Day 10
Population: The analysis population is based upon 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | -1.93 copies/mL |
| MK0518 200 mg b.i.d | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | -1.98 copies/mL |
| MK0518 400 mg b.i.d. | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | -1.66 copies/mL |
| MK0518 600 mg b.i.d. | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | -2.16 copies/mL |
| Placebo | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | -0.17 copies/mL |
Primary
Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.
Time frame: Week 240
Population: The analysis population was based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | Adverse experiences | 154 Participants |
| MK0518 100 mg b.i.d. | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | Serious adverse experiences | 25 Participants |
| MK0518 200 mg b.i.d | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | Adverse experiences | 35 Participants |
| MK0518 200 mg b.i.d | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | Serious adverse experiences | 4 Participants |
Primary
Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Time frame: Week 240
Population: Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 | 110 Participants |
| MK0518 200 mg b.i.d | Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 | 24 Participants |
Primary
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
Time frame: Week 24
Population: The analysis population is based upon 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.~All patients who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | 31 participants |
| MK0518 200 mg b.i.d | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | 27 participants |
| MK0518 400 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | 35 participants |
| MK0518 600 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | 32 participants |
| Placebo | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | 32 participants |
Primary
Number of Patients With Clinical Adverse Experiences (CAEs)
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Time frame: 48 weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 31 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 8 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 35 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 5 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 36 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 5 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 5 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 35 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 34 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 4 participants |
Primary
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Time frame: 10 days
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With CAEs | 4 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without CAEs | 3 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With Serious CAEs | 0 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without Serious CAEs | 7 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With CAEs | 2 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without Serious CAEs | 7 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without CAEs | 5 participants |
| MK0518 200 mg b.i.d | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With Serious CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without Serious CAEs | 6 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without CAEs | 3 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With Serious CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With CAEs | 3 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With CAEs | 5 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without CAEs | 3 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without Serious CAEs | 8 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With Serious CAEs | 0 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without Serious CAEs | 7 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With Serious CAEs | 0 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | Without CAEs | 2 participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | With CAEs | 5 participants |
Primary
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 144 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | With CAEs | 153 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | Without CAEs | 7 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | With serious CAEs | 18 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | Without serious CAEs | 142 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | Without serious CAEs | 34 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | With CAEs | 35 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | With serious CAEs | 4 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | Without CAEs | 3 participants |
Primary
Number of Patients With Serious CAEs (Cohort I and II Combined)
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 48 weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | With Serious CAEs | 2 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | Without Serious CAEs | 37 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs (Cohort I and II Combined) | With Serious CAEs | 5 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious CAEs (Cohort I and II Combined) | Without Serious CAEs | 35 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | With Serious CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | Without Serious CAEs | 41 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | Without Serious CAEs | 38 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious CAEs (Cohort I and II Combined) | With Serious CAEs | 2 participants |
| Placebo | Number of Patients With Serious CAEs (Cohort I and II Combined) | With Serious CAEs | 2 participants |
| Placebo | Number of Patients With Serious CAEs (Cohort I and II Combined) | Without Serious CAEs | 36 participants |
Secondary
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline and Week 96
Population: The analysis population is based upon 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. All patients switched to MK0518 400 mg b.i.d post 48 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 96 | 221.2 cells/mm3 |
| MK0518 200 mg b.i.d | Change From Baseline in CD4 Cell Count at Week 96 | 232.4 cells/mm3 |
Secondary
Change From Baseline in CD4 (T-helper) Cell Count at Week 240
Change in number of CD4 cells/mm\^3 from baseline to Week 240.
Time frame: Baseline and Week 240
Population: Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in CD4 (T-helper) Cell Count at Week 240 | 301.7 cells/mm^3 |
| MK0518 200 mg b.i.d | Change From Baseline in CD4 (T-helper) Cell Count at Week 240 | 275.6 cells/mm^3 |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Time frame: Baseline and Week 24
Population: The analysis population is based upon 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | 184 cells/mm3 |
| MK0518 200 mg b.i.d | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | 122 cells/mm3 |
| MK0518 400 mg b.i.d. | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | 147 cells/mm3 |
| MK0518 600 mg b.i.d. | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | 134 cells/mm3 |
| Placebo | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | 101 cells/mm3 |
Secondary
Change From Baseline in Plasma HIV RNA at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Time frame: Baseline and Week 240
Population: Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in Plasma HIV RNA at Week 240 | -2.29 Log10Copies/mL |
| MK0518 200 mg b.i.d | Change From Baseline in Plasma HIV RNA at Week 240 | -2.07 Log10Copies/mL |
Secondary
Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)
Time frame: Baseline and Week 24
Population: The analysis population is based upon 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | -2.39 copies/mL |
| MK0518 200 mg b.i.d | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | -2.20 copies/mL |
| MK0518 400 mg b.i.d. | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | -2.33 copies/mL |
| MK0518 600 mg b.i.d. | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | -2.49 copies/mL |
| Placebo | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | -2.44 copies/mL |
Secondary
Change From Baseline in Plasma HIV RNA at Week 96
Time frame: Baseline and Week 96
Population: The analysis population is based upon 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. All patients switched to MK0518 400 mg b.i.d post 48 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK0518 100 mg b.i.d. | Change From Baseline in Plasma HIV RNA at Week 96 | -2.30 copies/mL |
| MK0518 200 mg b.i.d | Change From Baseline in Plasma HIV RNA at Week 96 | -2.28 copies/mL |
Secondary
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Time frame: Week 240
Population: Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 | 115 Participants |
| MK0518 200 mg b.i.d | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 | 25 Participants |
Secondary
Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
Time frame: Week 24
Population: The analysis population is based upon 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | 28 participants |
| MK0518 200 mg b.i.d | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | 27 participants |
| MK0518 400 mg b.i.d. | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | 33 participants |
| MK0518 600 mg b.i.d. | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | 32 participants |
| Placebo | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | 31 participants |
Secondary
Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
Time frame: 96 Weeks
Population: The analysis population is based upon 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. All patients switched to MK0518 400 mg b.i.d post 48 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | HIV RNA <50 copies/mL | 133 participants |
| MK0518 100 mg b.i.d. | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | HIV RNA <400 copies/mL | 135 participants |
| MK0518 200 mg b.i.d | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | HIV RNA <50 copies/mL | 32 participants |
| MK0518 200 mg b.i.d | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | HIV RNA <400 copies/mL | 32 participants |
Other Pre-specified
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48
Time frame: 48 weeks
Population: The analysis population is based upon 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 100 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 38 participants |
| MK0518 200 mg b.i.d | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 34 participants |
| MK0518 400 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 40 participants |
| MK0518 600 mg b.i.d. | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 36 participants |
| Placebo | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 33 participants |
Other Pre-specified
Number of Patients That Discontinued With CAEs
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients That Discontinued With CAEs | Discontinued with CAEs | 0 participants |
| MK0518 100 mg b.i.d. | Number of Patients That Discontinued With CAEs | Did Not Discontinue with CAEs | 39 participants |
| MK0518 200 mg b.i.d | Number of Patients That Discontinued With CAEs | Discontinued with CAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients That Discontinued With CAEs | Did Not Discontinue with CAEs | 40 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs | Discontinued with CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With CAEs | Did Not Discontinue with CAEs | 41 participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs | Did Not Discontinue with CAEs | 40 participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With CAEs | Discontinued with CAEs | 0 participants |
| Placebo | Number of Patients That Discontinued With CAEs | Discontinued with CAEs | 0 participants |
| Placebo | Number of Patients That Discontinued With CAEs | Did Not Discontinue with CAEs | 38 participants |
Other Pre-specified
Number of Patients That Discontinued With LAEs
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients That Discontinued With LAEs | Discontinued With LAEs | 0 participants |
| MK0518 100 mg b.i.d. | Number of Patients That Discontinued With LAEs | Did Not Discontinue With LAEs | 39 participants |
| MK0518 200 mg b.i.d | Number of Patients That Discontinued With LAEs | Did Not Discontinue With LAEs | 40 participants |
| MK0518 200 mg b.i.d | Number of Patients That Discontinued With LAEs | Discontinued With LAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With LAEs | Did Not Discontinue With LAEs | 41 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With LAEs | Discontinued With LAEs | 0 participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With LAEs | Discontinued With LAEs | 1 participants |
| MK0518 600 mg b.i.d. | Number of Patients That Discontinued With LAEs | Did Not Discontinue With LAEs | 39 participants |
| Placebo | Number of Patients That Discontinued With LAEs | Did Not Discontinue With LAEs | 38 participants |
| Placebo | Number of Patients That Discontinued With LAEs | Discontinued With LAEs | 0 participants |
Other Pre-specified
Number of Patients With Drug-related CAEs
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 48 weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Drug-related CAEs | With drug-related CAEs | 18 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 21 participants |
| MK0518 200 mg b.i.d | Number of Patients With Drug-related CAEs | With drug-related CAEs | 20 participants |
| MK0518 200 mg b.i.d | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 20 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs | With drug-related CAEs | 19 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 22 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 21 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related CAEs | With drug-related CAEs | 19 participants |
| Placebo | Number of Patients With Drug-related CAEs | With drug-related CAEs | 27 participants |
| Placebo | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 11 participants |
Other Pre-specified
Number of Patients With Drug-related LAEs
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Drug-related LAEs | With drug-related LAEs | 3 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 36 participants |
| MK0518 200 mg b.i.d | Number of Patients With Drug-related LAEs | With drug-related LAEs | 6 participants |
| MK0518 200 mg b.i.d | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 34 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs | With drug-related LAEs | 4 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 37 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 38 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Drug-related LAEs | With drug-related LAEs | 2 participants |
| Placebo | Number of Patients With Drug-related LAEs | With drug-related LAEs | 3 participants |
| Placebo | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 35 participants |
Other Pre-specified
Number of Patients With Laboratory Adverse Experiences (LAEs)
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 48 Weeks
Population: The analysis population is based upon the All~Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 8 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 31 participants |
| MK0518 200 mg b.i.d | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 7 participants |
| MK0518 200 mg b.i.d | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 33 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 11 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 30 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 35 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 5 participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 8 participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 30 participants |
Other Pre-specified
Number of Patients With Serious Drug-related CAEs
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | With Serious drug-related CAEs | 0 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | Without Serious drug-related CAEs | 39 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious Drug-related CAEs | With Serious drug-related CAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious Drug-related CAEs | Without Serious drug-related CAEs | 40 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | With Serious drug-related CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | Without Serious drug-related CAEs | 41 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | Without Serious drug-related CAEs | 40 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related CAEs | With Serious drug-related CAEs | 0 participants |
| Placebo | Number of Patients With Serious Drug-related CAEs | With Serious drug-related CAEs | 0 participants |
| Placebo | Number of Patients With Serious Drug-related CAEs | Without Serious drug-related CAEs | 38 participants |
Other Pre-specified
Number of Patients With Serious Drug-related LAEs
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | Without serious LAEs | 39 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | With serious LAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious Drug-related LAEs | With serious LAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious Drug-related LAEs | Without serious LAEs | 40 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | Without serious LAEs | 41 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | With serious LAEs | 0 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | With serious LAEs | 0 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious Drug-related LAEs | Without serious LAEs | 40 participants |
| Placebo | Number of Patients With Serious Drug-related LAEs | Without serious LAEs | 38 participants |
| Placebo | Number of Patients With Serious Drug-related LAEs | With serious LAEs | 0 participants |
Other Pre-specified
Number of Patients With Serious LAEs
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 48 Weeks
Population: The analysis population is based upon the All Patients As Treated (APaT) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 100 mg b.i.d. | Number of Patients With Serious LAEs | Without serious LAEs | 39 participants |
| MK0518 100 mg b.i.d. | Number of Patients With Serious LAEs | With serious LAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious LAEs | With serious LAEs | 0 participants |
| MK0518 200 mg b.i.d | Number of Patients With Serious LAEs | Without serious LAEs | 40 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs | With serious LAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs | Without serious LAEs | 41 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious LAEs | With serious LAEs | 0 participants |
| MK0518 600 mg b.i.d. | Number of Patients With Serious LAEs | Without serious LAEs | 40 participants |
| Placebo | Number of Patients With Serious LAEs | Without serious LAEs | 38 participants |
| Placebo | Number of Patients With Serious LAEs | With serious LAEs | 0 participants |