HIV-1 InfectionsNCT01078233

Observational Data Analysis in EuroSIDA (MK-0518-058)

An observational study of HIV-1 Infections, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV-1 Infections
How many people: 6,617 participants
Where: No sites listed yet
Study dates: 5 May 2008to 6 Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Adults 16 years old and older in the EuroSIDA database

Who may be able to join

Adults 16 years old and older with HIV-1

Who cannot join

Subjects will be excluded if they have no prospective follow up

About this study

Official title: Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period

The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.

Read the detailed description

Time Perspective: Retrospective and Prospective

Conditions: HIV-1 Infections
Keywords: HIV, antiretroviral treatment, HIV Cohort, Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01078233
Study group	Role	What they receive
Raltegravir Cohort		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		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		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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
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.
Measured: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
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.
Measured: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Incidence of All-Cause Mortality
All participant deaths were recorded
Measured: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20086 Mar 2014

First posted2 Mar 2010 (estimated)
Study start5 May 2008
Primary completion6 Mar 2014
Study completion6 Mar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 6,617 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078233
Sponsor's protocol ID: 0518-058
Other IDs: 2010_020, EP08025.005
Status last verified: Nov 2019
First submitted: 26 Feb 2010
Last updated: 25 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fatkenheuer G, Yust I, Schmid P, Gottfredsson M, Khromova I, Jilich D, Flisiak R, Smidt J, Rozentale B, Radoi R, Losso MH, Lundgren JD, Mocroft A; EuroSIDA Study Group. Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens. HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.
PubMed 28984429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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RecruitingPhase 1
Dasatinib for HIV-1 Reservoir Reduction
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RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
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All HIV-1 Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period
ClinicalTrials.gov ID: NCT01078233
Acronym / sponsor ID: 0518-058
Conditions: HIV-1 Infections
Keywords: HIV, antiretroviral treatment, HIV Cohort, Treatment
Study type: Observational
Recruitment status: Completed
Enrolment: 6,617 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Copenhagen HIV Programme
Study start: 5 May 2008 (actual)
Primary completion: 6 Mar 2014 (actual)
Study completion: 6 Mar 2014 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 17 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
Raltegravir Cohort	–	–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	–	–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	–	–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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Adults 16 years old and older in the EuroSIDA database

Key inclusion criteria (1 listed)

Adults 16 years old and older with HIV-1

Key exclusion criteria (1 listed)

Subjects will be excluded if they have no prospective follow up

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of Malignancy
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)
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
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)
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
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)
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
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)
All participant deaths were recorded

Results and safety

Results posted to the registry on 17 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raltegravir Cohort Only	656	656
Historical and Raltegravir Cohorts Only	296	296
Historical Cohort Only	1,681	1,681
Historical and Concurrent Cohorts	631	631
Concurrent Cohort Only	3,199	3,199
Concurrent and Raltegravir Cohorts Only	154	154

Primary outcome: Incidence of Malignancy

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). Number (95% Confidence Interval). Unit: Events per 100 person-years of follow-up

Measure	Raltegravir Cohort n = 1150	Historical Cohort n = 2608	Concurrent Cohort n = 3984
Value	1.29 (0.93 to 1.80)	1.17 (0.84 to 1.64)	0.81 (0.65 to 1.00)

Population analysed: 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.

Primary outcome: Incidence of Clinically Important Hepatic Events

Measure	Raltegravir Cohort n = 1150	Historical Cohort n = 2608	Concurrent Cohort n = 3984
Value	0.11 (0.04 to 0.34)	0.90 (0.61 to 1.32)	0.28 (0.19 to 0.40)

Population analysed: 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.

Primary outcome: Incidence of Lipodystrophy

Measure	Raltegravir Cohort n = 1150	Historical Cohort n = 2608	Concurrent Cohort n = 3984
Value	0.15 (0.05 to 0.39)	1.04 (0.73 to 1.48)	0.64 (0.50 to 0.81)

Population analysed: 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.

Primary outcome: Incidence of All-Cause Mortality

Measure	Raltegravir Cohort n = 1150	Historical Cohort n = 2608	Concurrent Cohort n = 3984
Value	0.86 (0.58 to 1.29)	1.27 (0.92 to 1.75)	0.68 (0.54 to 0.86)

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir Cohort	0 of 0	0 of 0	Not reported
Historical Cohort	0 of 0	0 of 0	Not reported
Concurrent Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28984429Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fatkenheuer G, Yust I, Schmid P, Gottfredsson M, Khromova I, Jilich D, Flisiak R, Smidt J, Rozentale B, Radoi R, Losso MH, Lundgren JD, Mocroft A; EuroSIDA Study Group. Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens. HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.
EUPAS Register (EUPAS17912)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for HIV-1 Infections

Not yet recruitingObservational study
HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM)
HIV Infection
Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
HIV-1-infection
RecruitingPhase 1
Dasatinib for HIV-1 Reservoir Reduction
HIV Infections
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Human Immunodeficiency Virus (HIV) Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1 Infections, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Malignancy (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.