Trial Outcomes & Findings for Observational Data Analysis in EuroSIDA (MK-0518-058) (NCT NCT01078233)
NCT ID: NCT01078233
Last Updated: 2019-11-25
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
6617 participants
Primary outcome timeframe
Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Results posted on
2019-11-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
656
|
296
|
1681
|
631
|
3199
|
154
|
|
Overall Study
COMPLETED
|
656
|
296
|
1681
|
631
|
3199
|
154
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Data Analysis in EuroSIDA (MK-0518-058)
Baseline characteristics by cohort
| Measure |
Raltegravir Cohort Only
n=656 Participants
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.
|
Historical and Raltegravir Cohorts Only
n=296 Participants
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.
|
Historical Cohort Only
n=1681 Participants
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.
|
Historical and Concurrent Cohorts
n=631 Participants
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.
|
Concurrent Cohort Only
n=3199 Participants
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.
|
Concurrent and Raltegravir Cohorts Only
n=154 Participants
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.
|
Total
n=6617 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49 Years
n=5 Participants
|
49 Years
n=7 Participants
|
44 Years
n=5 Participants
|
47 Years
n=4 Participants
|
42 Years
n=21 Participants
|
50 Years
n=8 Participants
|
44 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
873 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
1744 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
480 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
1259 Participants
n=5 Participants
|
457 Participants
n=4 Participants
|
2326 Participants
n=21 Participants
|
127 Participants
n=8 Participants
|
4873 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Raltegravir Cohort
n=2712 Person years of follow-up
Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
|
Historical Cohort
n=2895 Person years of follow-up
Participants with HIV-1 infection who 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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
|
Concurrent Cohort
n=3984 Participants
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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
|
|---|---|---|---|
|
Incidence of Malignancy
|
1.29 Events per 100 person-years of follow-up
Interval 0.93 to 1.8
|
1.17 Events per 100 person-years of follow-up
Interval 0.84 to 1.64
|
0.81 Events per 100 person-years of follow-up
Interval 0.65 to 1.0
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Raltegravir Cohort
n=2750 Person years of follow-up
Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
|
Historical Cohort
n=2891 Person years of follow-up
Participants with HIV-1 infection who 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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
|
Concurrent Cohort
n=10086 Person years of follow-up
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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
|
|---|---|---|---|
|
Incidence of Clinically Important Hepatic Events
|
0.11 Events per 100 person-years of follow-up
Interval 0.04 to 0.34
|
0.90 Events per 100 person-years of follow-up
Interval 0.61 to 1.32
|
0.28 Events per 100 person-years of follow-up
Interval 0.19 to 0.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Raltegravir Cohort
n=2750 Person years of follow-up
Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
|
Historical Cohort
n=2893 Person years of follow-up
Participants with HIV-1 infection who 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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
|
Concurrent Cohort
n=10033 Person years of follow-up
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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
|
|---|---|---|---|
|
Incidence of Lipodystrophy
|
0.15 Events per 100 person-years of follow-up
Interval 0.05 to 0.39
|
1.04 Events per 100 person-years of follow-up
Interval 0.73 to 1.48
|
0.64 Events per 100 person-years of follow-up
Interval 0.5 to 0.81
|
PRIMARY outcome
Timeframe: 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.
All participant deaths were recorded
Outcome measures
| Measure |
Raltegravir Cohort
n=2782 Person years of follow-up
Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
|
Historical Cohort
n=2913 Person years of follow-up
Participants with HIV-1 infection who 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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
|
Concurrent Cohort
n=10149 Person years of follow-up
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. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
|
|---|---|---|---|
|
Incidence of All-Cause Mortality
|
0.86 Events per 100 person-years of follow-up
Interval 0.58 to 1.29
|
1.27 Events per 100 person-years of follow-up
Interval 0.92 to 1.75
|
0.68 Events per 100 person-years of follow-up
Interval 0.54 to 0.86
|
Adverse Events
Raltegravir Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Concurrent Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place