HIV Infection
Conditions
Keywords
treatment experienced
Brief summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.
Interventions
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
DRUGComparator: KALETRA™ (lopinavir (+) ritonavir )
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
DRUGComparator: placebo
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
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 is at least 18 years of age * Patient is Human Immunodeficiency Virus (HIV) positive * Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen * Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy * Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion criteria
* Patient is or plans to become pregnant, or nursing a child * Patient plans to donate eggs or impregnate/donate sperm * Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy * Patient is currently receiving a second protease inhibitor in addition to KALETRA * Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids * Patient has used another experimental HIV-integrase inhibitor * Patient has a current (active) diagnosis of acute hepatitis due to any cause * Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 | Week 24 | — |
| Median Percent Change From Baseline in Serum Triglyceride at Week 12 | Baseline and Week 12 | Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. |
| Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 | — |
| Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | — |
| Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseline and Week 12 | — |
| Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 | Baseline and Week 12 | — |
| Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | 24 Week last patient last visit | An adverse experience 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 (Merck & Co., Inc.) product, whether or not considered related to the use of the product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 | Baseline and Week 24 | — |
| Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 | Baseline and Week 24 | — |
| Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Baseline and Week 24 | — |
| Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Baseline and Week 24 | — |
| Median Percent Change From Baseline in Serum Triglyceride at Week 24 | Baseline and Week 24 | Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Discontinued Due to CAEs Through 24 Weeks | 24 Week last patient last visit | — |
| Number of Patients That Died by 24 Week Last Patient Last Visit | 24 Week last patient last visit | — |
| Number of Patients With Serious Drug-related CAEs Through 24 Weeks | 24 Week last patient last visit | 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 judgement |
| Number of Patients With Drug-related CAEs Through 24 Weeks | 24 Week last patient last visit | Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs. |
| Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks | 24 Week last patient last visit | Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs |
| Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | 24 Week last patient last visit | 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 (Merck & Co., Inc.) product, whether or not considered related to the use of the product |
| Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks | 24 Week last patient last visit | — |
| Number of Patients With Serious LAEs Through 24 Weeks | 24 Week last patient last visit | 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 That Discontinued Due to LAEs Through 24 Weeks | 24 Week last patient last visit | — |
| Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks | 24 Week last patient last visit | Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs. |
| Number of Patients With Serious CAEs Through 24 Weeks | 24 Week last patient last visit | 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 |
Participant flow
Recruitment details
Phase III; First Patient In: 20-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 31-Oct-2008 47 Sites (US, Canada, Denmark, Germany, Italy, Portugal, Spain, United Kingdom, and Australia).
Pre-assignment details
HIV-seropositive patients who were ≥18 years old, had documented HIV RNA \<50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA \>50 copies/mL for at least 3 months.
Participants by arm
| Arm | Count |
|---|---|
| MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food | 174 |
| KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food | 174 |
| Total | 348 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Never Treated | 3 | 1 |
| Overall Study | Physician Decision | 4 | 2 |
| Overall Study | Progressive Disease | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | MK0518 400 mg b.i.d. | KALETRA™ 400/100 mg b.i.d. | Total |
|---|---|---|---|
| Age, Continuous | 44.4 years | 43.6 years | 44.0 years |
| Cluster of Differentiation 4 (CD4) Cell Count | 477.6 cells/mm3 | 508.2 cells/mm3 | 492.9 cells/mm3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 23 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 151 Participants | 300 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting (non-random) serum cholesterol | 215.3 mg/dL STANDARD_DEVIATION 48.2 | 203.9 mg/dL STANDARD_DEVIATION 52.3 | 209.6 mg/dL STANDARD_DEVIATION 50.6 |
| Fasting (non-random) serum High Density Lipoprotein-Cholesterol (HDL-C) | 48.8 mg/dL STANDARD_DEVIATION 16.4 | 47.1 mg/dL STANDARD_DEVIATION 14 | 47.9 mg/dL STANDARD_DEVIATION 15.2 |
| Fasting (non-random) serum Low Density Lipoprotein-Cholesterol (LDL-C) | 115.3 mg/dL STANDARD_DEVIATION 40.3 | 104.8 mg/dL STANDARD_DEVIATION 35.9 | 110.0 mg/dL STANDARD_DEVIATION 38.5 |
| Fasting (non-random) serum triglyceride | 189.5 mg/dL STANDARD_DEVIATION 134 | 162.0 mg/dL STANDARD_DEVIATION 112.6 | 175.0 mg/dL STANDARD_DEVIATION 126.5 |
| Non-HDL-C | 165.5 mg/dL STANDARD_DEVIATION 48.5 | 156.8 mg/dL STANDARD_DEVIATION 53 | 161.1 mg/dL STANDARD_DEVIATION 50.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 28 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 146 Participants | 141 Participants | 287 Participants |
| Sex: Female, Male Female | 28 Participants | 45 Participants | 73 Participants |
| Sex: Female, Male Male | 146 Participants | 129 Participants | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 76 / 174 | 77 / 174 |
| serious Total, serious adverse events | 15 / 174 | 10 / 174 |
Outcome results
Primary
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Time frame: Baseline and Week 12
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 | -12.83 Percent Change | Standard Deviation 12.19 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 | 0.70 Percent Change | Standard Deviation 14.69 |
Primary
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | -0.86 Percent Change | Standard Deviation 18.71 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | 0.78 Percent Change | Standard Deviation 25.38 |
Primary
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -2.43 Percent Change | Standard Deviation 22.63 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 2.05 Percent Change | Standard Deviation 29.87 |
Primary
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -15.17 Percent Change | Standard Deviation 15.8 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | 2.31 Percent Change | Standard Deviation 19.37 |
Primary
Median Percent Change From Baseline in Serum Triglyceride at Week 12
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time frame: Baseline and Week 12
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Median Percent Change From Baseline in Serum Triglyceride at Week 12 | -41.50 Percent Change | Standard Deviation 35.37 |
| KALETRA™ 400/100 mg b.i.d. | Median Percent Change From Baseline in Serum Triglyceride at Week 12 | 3.56 Percent Change | Standard Deviation 59.36 |
Primary
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
An adverse experience 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 (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | With CAEs | 109 Participants |
| MK0518 400 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | Without CAEs | 65 Participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | With CAEs | 106 Participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | Without CAEs | 68 Participants |
Primary
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Time frame: Week 24
Population: Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA \<50 copies/mL at Week 12 and Week 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 | 139 Participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 | 152 Participants |
Secondary
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Time frame: Baseline and Week 24
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 | -13.81 Percent Change | Standard Deviation 12.02 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 | 2.70 Percent Change | Standard Deviation 17.69 |
Secondary
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline and Week 24
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | -4.42 Percent Change | Standard Deviation 17.8 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | -1.70 Percent Change | Standard Deviation 20.24 |
Secondary
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time frame: Baseline and Week 24
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | -1.12 Percent Change | Standard Deviation 23.66 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | 8.54 Percent Change | Standard Deviation 27.44 |
Secondary
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Time frame: Baseline and Week 24
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 | -15.03 Percent Change | Standard Deviation 16.52 |
| KALETRA™ 400/100 mg b.i.d. | Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 | 5.53 Percent Change | Standard Deviation 21.96 |
Secondary
Median Percent Change From Baseline in Serum Triglyceride at Week 24
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time frame: Baseline and Week 24
Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Median Percent Change From Baseline in Serum Triglyceride at Week 24 | -44.53 Percent Change | Standard Deviation 31.43 |
| KALETRA™ 400/100 mg b.i.d. | Median Percent Change From Baseline in Serum Triglyceride at Week 24 | 6.14 Percent Change | Standard Deviation 57.8 |
Other Pre-specified
Number of Patients That Died by 24 Week Last Patient Last Visit
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients That Died by 24 Week Last Patient Last Visit | Died | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Died by 24 Week Last Patient Last Visit | Did Not Die | 174 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Died by 24 Week Last Patient Last Visit | Died | 0 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Died by 24 Week Last Patient Last Visit | Did Not Die | 174 participants |
Other Pre-specified
Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to CAEs Through 24 Weeks | Discontinued with CAEs | 4 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to CAEs Through 24 Weeks | Did not Discontinue with CAEs | 170 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to CAEs Through 24 Weeks | Discontinued with CAEs | 4 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to CAEs Through 24 Weeks | Did not Discontinue with CAEs | 170 participants |
Other Pre-specified
Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks | Discontinued with drug related CAEs | 2 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks | Did Not Discontinue with drug related CAEs | 172 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks | Discontinued with drug related CAEs | 3 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks | Did Not Discontinue with drug related CAEs | 171 participants |
Other Pre-specified
Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to LAEs Through 24 Weeks | Discontinued with LAEs | 2 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued Due to LAEs Through 24 Weeks | Did Not Discontinue with LAEs | 172 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to LAEs Through 24 Weeks | Discontinued with LAEs | 1 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued Due to LAEs Through 24 Weeks | Did Not Discontinue with LAEs | 173 participants |
Other Pre-specified
Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks | Discontinued with Drug Related LAEs | 2 participants |
| MK0518 400 mg b.i.d. | Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks | Did Not Discontinue with Drug Related LAEs | 172 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks | Discontinued with Drug Related LAEs | 1 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks | Did Not Discontinue with Drug Related LAEs | 173 participants |
Other Pre-specified
Number of Patients With Drug-related CAEs Through 24 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs Through 24 Weeks | With drug-related CAEs | 24 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related CAEs Through 24 Weeks | Without drug-related CAEs | 150 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Drug-related CAEs Through 24 Weeks | With drug-related CAEs | 19 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Drug-related CAEs Through 24 Weeks | Without drug-related CAEs | 155 participants |
Other Pre-specified
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks | With LAEs | 6 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks | Without LAEs | 168 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks | With LAEs | 2 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks | Without LAEs | 172 participants |
Other Pre-specified
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 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 (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | With LAEs | 11 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | Without LAEs | 163 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | With LAEs | 7 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | Without LAEs | 167 participants |
Other Pre-specified
Number of Patients With Serious CAEs Through 24 Weeks
Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs Through 24 Weeks | With Serious CAEs | 15 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious CAEs Through 24 Weeks | Without Serious CAEs | 159 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious CAEs Through 24 Weeks | With Serious CAEs | 10 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious CAEs Through 24 Weeks | Without Serious CAEs | 164 participants |
Other Pre-specified
Number of Patients With Serious Drug-related CAEs Through 24 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 judgement
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs Through 24 Weeks | With Serious drug-related CAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious Drug-related CAEs Through 24 Weeks | Without Serious drug-related CAEs | 174 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious Drug-related CAEs Through 24 Weeks | With Serious drug-related CAEs | 0 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious Drug-related CAEs Through 24 Weeks | Without Serious drug-related CAEs | 174 participants |
Other Pre-specified
Number of Patients With Serious LAEs Through 24 Weeks
Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose
Time frame: 24 Week last patient last visit
Population: All patients who took study medication were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs Through 24 Weeks | With LAEs | 0 participants |
| MK0518 400 mg b.i.d. | Number of Patients With Serious LAEs Through 24 Weeks | Without LAEs | 174 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious LAEs Through 24 Weeks | With LAEs | 0 participants |
| KALETRA™ 400/100 mg b.i.d. | Number of Patients With Serious LAEs Through 24 Weeks | Without LAEs | 174 participants |