HIV-1 Infections
Conditions
Keywords
HIV, antiretroviral treatment, HIV Cohort, Treatment
Brief summary
The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.
Detailed description
Time Perspective: Retrospective and Prospective
Interventions
None listed
Sponsors
EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 16 years old and older with HIV-1
Exclusion criteria
* Subjects will be excluded if they have no prospective follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Malignancy | Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) | All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant. |
| Incidence of Clinically Important Hepatic Events | Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) | Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation. |
| Incidence of Lipodystrophy | Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) | Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location. |
| Incidence of All-Cause Mortality | Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013) | All participant deaths were recorded |
Participant flow
Pre-assignment details
The analyses in this study are based on data collected from a cohort of HIV-1-infected participants in a setting of routine clinical care in Europe (EuroSIDA Cohort Study). Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir Cohort Only Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort. | 656 |
| Historical and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort. | 296 |
| Historical Cohort Only Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort. | 1,681 |
| Historical and Concurrent Cohorts Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort. | 631 |
| Concurrent Cohort Only Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort. | 3,199 |
| Concurrent and Raltegravir Cohorts Only Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort. | 154 |
| Total | 6,617 |
Baseline characteristics
| Characteristic | Raltegravir Cohort Only | Historical and Raltegravir Cohorts Only | Historical Cohort Only | Historical and Concurrent Cohorts | Concurrent Cohort Only | Concurrent and Raltegravir Cohorts Only | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 49 Years | 49 Years | 44 Years | 47 Years | 42 Years | 50 Years | 44 Years |
| Sex: Female, Male Female | 176 Participants | 72 Participants | 422 Participants | 174 Participants | 873 Participants | 27 Participants | 1744 Participants |
| Sex: Female, Male Male | 480 Participants | 224 Participants | 1259 Participants | 457 Participants | 2326 Participants | 127 Participants | 4873 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of All-Cause Mortality
All participant deaths were recorded
Time frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Population: Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raltegravir Cohort | Incidence of All-Cause Mortality | 0.86 Events per 100 person-years of follow-up |
| Historical Cohort | Incidence of All-Cause Mortality | 1.27 Events per 100 person-years of follow-up |
| Concurrent Cohort | Incidence of All-Cause Mortality | 0.68 Events per 100 person-years of follow-up |
Primary
Incidence of Clinically Important Hepatic Events
Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.
Time frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Population: Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raltegravir Cohort | Incidence of Clinically Important Hepatic Events | 0.11 Events per 100 person-years of follow-up |
| Historical Cohort | Incidence of Clinically Important Hepatic Events | 0.90 Events per 100 person-years of follow-up |
| Concurrent Cohort | Incidence of Clinically Important Hepatic Events | 0.28 Events per 100 person-years of follow-up |
Primary
Incidence of Lipodystrophy
Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.
Time frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Population: Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raltegravir Cohort | Incidence of Lipodystrophy | 0.15 Events per 100 person-years of follow-up |
| Historical Cohort | Incidence of Lipodystrophy | 1.04 Events per 100 person-years of follow-up |
| Concurrent Cohort | Incidence of Lipodystrophy | 0.64 Events per 100 person-years of follow-up |
Primary
Incidence of Malignancy
All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.
Time frame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Population: Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raltegravir Cohort | Incidence of Malignancy | 1.29 Events per 100 person-years of follow-up |
| Historical Cohort | Incidence of Malignancy | 1.17 Events per 100 person-years of follow-up |
| Concurrent Cohort | Incidence of Malignancy | 0.81 Events per 100 person-years of follow-up |