Human Immunodeficiency Virus
Conditions
Keywords
Maraviroc, HIV-1, Safety, Non-interventional
Brief summary
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
Detailed description
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Interventions
DRUGMaraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
DRUGOptimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
Sponsors
Pfizer
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment experienced, HIV-1 infected patients * 18 years or older * Receive an approved assay for determination of HIV-1 tropism
Exclusion criteria
* Pregnant or lactating * Using CCR5 inhibitor other than maraviroc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI). |
| Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Density Rate Per 1000 Participant-Years for Incidence of Liver Failure | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported. |
| Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported. |
| Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI. |
| Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. |
| Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported. |
| Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported. |
| Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. |
| Percentage of Participants With All-Cause Mortality | Up to 5 years following enrollment | All-cause death was defined as the death due to any cause during the course of study. |
Countries
Belgium, Brazil, Canada, France, Germany, Greece, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.
Participants by arm
| Arm | Count |
|---|---|
| Maraviroc Exposed Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. | 1,316 |
| Maraviroc Unexposed HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. | 1,130 |
| Total | 2,446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death recorded on subject summary pages | 75 | 75 |
| Overall Study | Does not meet entrance criteria | 19 | 21 |
| Overall Study | Lost to Follow-up | 203 | 264 |
| Overall Study | Other | 123 | 108 |
| Overall Study | Site closed | 8 | 0 |
| Overall Study | Withdrawal by Subject | 74 | 65 |
| Overall Study | Withdrawn due to pregnancy | 0 | 1 |
Baseline characteristics
| Characteristic | Maraviroc Exposed | Maraviroc Unexposed | Total |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 9.3 | 44.3 years STANDARD_DEVIATION 10 | 45.6 years STANDARD_DEVIATION 9.7 |
| Race/Ethnicity, Customized Asian | 13 Participants | 7 Participants | 20 Participants |
| Race/Ethnicity, Customized Black | 271 Participants | 390 Participants | 661 Participants |
| Race/Ethnicity, Customized Other | 48 Participants | 48 Participants | 96 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 983 Participants | 684 Participants | 1667 Participants |
| Sex: Female, Male Female | 275 Participants | 265 Participants | 540 Participants |
| Sex: Female, Male Male | 1041 Participants | 865 Participants | 1906 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 75 / 1,316 | 79 / 1,130 |
| other Total, other adverse events | 111 / 1,316 | 34 / 1,130 |
| serious Total, serious adverse events | 435 / 1,316 | 352 / 1,130 |
Outcome results
Primary
Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | All Malignancies | 12.49 events per 1000 participant-years |
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | AIDS defining Malignancies | 2.31 events per 1000 participant-years |
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Non-AIDS defining Malignancies | 9.87 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Non-AIDS defining Malignancies | 9.86 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | All Malignancies | 13.54 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | AIDS defining Malignancies | 3.31 events per 1000 participant-years |
Comparison: All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.64, 1.33]
Comparison: AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.32, 1.52]
Comparison: Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.66, 1.52]
Primary
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections
Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections | 22.36 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections | 28.70 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.61, 0.99]
Primary
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | 14.39 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | 15.64 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.66, 1.28]
Primary
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | 2.08 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | 3.37 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.35, 1.1]
Primary
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | 5.65 events per 1000 participant-years |
| Maraviroc Unexposed | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | 5.99 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.95% CI: [0.59, 1.52]
Primary
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | All Malignancies | 12.87 events per 1000 participant-years |
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | AIDS defining Malignancies | 2.31 events per 1000 participant-years |
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Non-AIDS defining Malignancies | 10.56 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | All Malignancies | 13.69 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | AIDS defining Malignancies | 3.71 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Non-AIDS defining Malignancies | 9.98 events per 1000 participant-years |
Comparison: All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.66, 1.33]
Comparison: AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.29, 1.31]
Comparison: Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.71, 1.58]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections
Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | 22.28 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | 41.77 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.95% CI: [0.42, 0.67]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | 14.41 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | 18.33 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.57, 1.08]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause
Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause | 0.77 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause | 1.16 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.18, 2.47]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Liver Failure
Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Liver Failure | 2.50 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Liver Failure | 2.55 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.44, 2.18]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | 4.80 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | 5.34 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.51, 1.59]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | 8.26 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | 7.43 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.7, 1.76]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis
Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis | 0.77 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis | 0.70 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.25, 4.93]
Primary
Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis
Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | 0.38 events per 1000 participant-years |
| Maraviroc Unexposed | Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | 0.46 events per 1000 participant-years |
Comparison: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.95% CI: [0.12, 5.88]
Primary
Percentage of Participants With All-Cause Mortality
All-cause death was defined as the death due to any cause during the course of study.
Time frame: Up to 5 years following enrollment
Population: Safety analysis set included all participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc Exposed | Percentage of Participants With All-Cause Mortality | 5.7 Percentage of participants |
| Maraviroc Unexposed | Percentage of Participants With All-Cause Mortality | 7.0 Percentage of participants |
p-value: 0.622595% CI: [0.66, 1.28]Regression, Cox