A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen) (WIP)
15. april 2016 oppdatert av: Merck Sharp & Dohme LLC
A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany
This is an observational, non-comparative, multicenter, open-label study.
Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks.
In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks.
Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug.
The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
451
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults with confirmed HIV-1 infection
Beskrivelse
Inclusion Criteria
The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
- Is a minimum age of 18 years (adults) or 50 years (aging participants);
- Is male or female;
- Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice);
- Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;
- Has any cluster of differentiation (CD4) cell (specialized white blood cell) count upon enrollment on the study.
Exclusion criteria
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
- For which Raltegravir, or its ingredients, are contraindicated;
- Has intolerance to Raltegravir, or its ingredients;
- If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation during the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Overall Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
|
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
Andre navn:
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks
Andre navn:
|
|
Aging Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort). |
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
Andre navn:
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
|
Baseline and 48 weeks
|
|
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
|
Baseline and 48 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 96 weeks
|
The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.
|
Baseline and 96 weeks
|
|
HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 96 weeks
|
The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.
|
Baseline and 96 weeks
|
|
Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 96 weeks
|
Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment.
A positive change from baseline indicates an increase in CD4+ T-cell count.
|
Baseline and 96 weeks
|
|
HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
|
Baseline and 48 weeks
|
|
Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined.
A positive change from baseline indicates an increase in CD4+ T-cell count.
|
Baseline and 48 weeks
|
|
Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment).
Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein.
The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%.
The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population.
The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
|
Baseline and 48 weeks
|
|
Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Tidsramme: Baseline and 48 weeks
|
Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir.
The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%.
The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
|
Baseline and 48 weeks
|
|
Percentage of Aging Participants With Concomitant Diseases at Baseline
Tidsramme: Baseline
|
The percentage of aging participants with Baseline comorbidities was reported.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
|
Baseline
|
|
Percentage of Aging Participants Taking Concomitant Medications at Baseline
Tidsramme: Baseline
|
The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
|
Baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Friis-Moller N, Thiebaut R, Reiss P, Weber R, Monforte AD, De Wit S, El-Sadr W, Fontas E, Worm S, Kirk O, Phillips A, Sabin CA, Lundgren JD, Law MG; DAD study group. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):491-501. doi: 10.1097/HJR.0b013e328336a150.
- Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991 Jan;83(1):356-62. doi: 10.1161/01.cir.83.1.356. No abstract available.
- Naumann U, Moll A, Schleehauf D, Lutz T, Schmidt W, Jaeger H, Funke B, Witte V. Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 Nov 14. Erratum In: Int J STD AIDS. 2017 Jun;28(7):738.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. april 2015
Studiet fullført (Faktiske)
1. april 2015
Datoer for studieregistrering
Først innsendt
30. september 2010
Først innsendt som oppfylte QC-kriteriene
30. september 2010
Først lagt ut (Anslag)
4. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. april 2016
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Infeksjoner
- Ervervet immunsviktsyndrom
- Immunologiske mangelsyndromer
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- HIV-integrasehemmere
- Integrasehemmere
- Raltegravir kalium
Andre studie-ID-numre
- 0518-145
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