- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01078246
Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)
24 juli 2018 uppdaterad av: Merck Sharp & Dohme LLC
Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network
The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Study participants contributed data to one or more of 3 cohorts: 1) Historical Cohort: HIV-infected participants treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA), 2) Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007, and 3) Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007.
Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
Studietyp
Observationell
Inskrivning (Faktisk)
7124
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults 18 years old and older
Beskrivning
Inclusion Criteria:
- Historical Cohort: HIV-infected participant treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA)
- Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
- Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
- All participants must have at least one year of continuous membership with KP prior to date when the participant received the first dispensed prescription for study drug (index date) to allow for the assessment of medical and treatment history
Exclusion Criteria:
- Less than 18 years of age
- Do not receive their medications through the KP pharmacy system
- Do not receive their laboratory examinations through the KP system
- Participating in the raltegravir phase III or expanded access program
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Raltegravir Cohort Only
Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort).
These participants contributed data to the Raltegravir Cohort only.
|
Historical and Raltegravir Cohorts Only
Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort).
These participants contributed data to the Historical and Raltegravir Cohorts only.
|
Historical Cohort Only
Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort).
These participants contributed data to the Historical Cohort only.
|
Historical and Concurrent Cohorts Only
Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort).
These participants contributed data to the Historical and Concurrent Cohorts only.
|
Concurrent Cohort Only
Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort).
These participants contributed data to the Concurrent Cohort only.
|
Concurrent and Raltegravir Cohorts Only
Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort).
These participants contributed data to the Concurrent and Raltegravir Cohorts only.
|
Historical, Concurrent and Raltegravir Cohorts
Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort).
These participants contributed data to all three cohorts.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of AIDS-defining and Non-AIDS-defining Malignancy
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries.
The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g.
cutaneous Kaposi's sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Incidence of Clinically Important Hepatic Events
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations.
Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Incidence of Clinically Important Skin Events
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Significant skin events (e.g.
Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations.
The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications.
Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g.
prednisone) administration.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Incidence of Clinically Important Muscle Events
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Significant muscle events (e.g.
rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations.
The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase.
The number of muscle events did not meet the threshold for statistical analysis per protocol.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Incidence of Lipodystrophy
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Lipodystrophy (e.g.
lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations.
The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g.
sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of Clinically Important Cardiovascular Events
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes.
The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g.
percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Incidence of All-cause Mortality
Tidsram: Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates.
Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files.
Incidence is reported as unadjusted, crude rates.
|
Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 augusti 2009
Primärt slutförande (Faktisk)
9 december 2014
Avslutad studie (Faktisk)
9 december 2014
Studieregistreringsdatum
Först inskickad
26 februari 2010
Först inskickad som uppfyllde QC-kriterierna
1 mars 2010
Första postat (Uppskatta)
2 mars 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 0518-268
- EP08025.006 (Annan identifierare: Merck)
- 2010_021 (Annan identifierare: Merck)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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