- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01061957
Raltegravir Treatment in Patients Failing Highly Active Antiretroviral Therapy (HAART) in Denmark
3. februar 2010 oppdatert av: Rigshospitalet, Denmark
Clinical, Virological and Immunological Course in Danish Patients With Triple Class Failure Receiving Raltegravir as Part of a Salvage Regimen.
Raltegravir is the first integrase inhibitor approved for treatment of HIV infected patients harboring multiresistant viruses.
The drug has been proved effective in both trials and clinical settings, but the long-term efficacy is not described and the effect compared to treatment in Highly active antiretroviral therapy (HAART) naive patients remains to be established.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Highly active antiretroviral therapy (HAART) was introduced more than a decade ago and the therapy has decreased mortality and morbidity of HIV patients dramatically.
The first HAART regimens were combined of nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs).
Especially the early regimes carried a substantial risk of failure and subsequent development of resistance to the three drug classes.
Thus there has been a need for development of new drugs with activity against viruses resistant to the classical HAART regimens either as new drugs from the old classes without (or with limited) cross resistance to the older compounds or drugs from new classes with new antiretroviral mechanisms.
The optimal choice for salvage therapy for HIV infected patients has been shown to require at least two, and preferably three, fully active drugs.
Until recently, salvage regimens used to treat patients harbouring multidrug-resistant HIV generally included only one new agent from the classic drug classes added to an optimized background therapy which did not contain any fully active agents.
This approach, conditioned by limited drug options, put patients at high risk of virological failure and resistance to the new agent, as well as to other agents in the same drug classes.
A breakthrough has been the resent development of integrase inhibitors, which is a new class of antiretroviral drugs.
One of these drugs - raltegravir - has demonstrated its activity in patients with virological failure on classical antiretroviral drugs.
In the BENCHMARK randomized clinical trials, which were conducted in HIV-infected patients with limited treatment options, 62% of patients taking raltegravir plus optimized background treatment achieved plasma HIV RNA levels <50 copies/mL at week 48.
Although the drug - often used together with other new drugs - has been proved effective in clinical trials and recently in "real life" clinical settings, the long-term efficacy is not described and the effect compared to treatment in HAART naive patients remains to be established.
In a nationwide cohort of HIV infected patients, we identified the patients, who initiated raltegravir due to virological failure and a matched control cohort of patients initiating HAART for the first time.
We compared these two cohorts with respect to virological suppression, gain in CD4 count and time to first change of initial regimen.
Studietype
Observasjonsmessig
Registrering (Faktiske)
96
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Copenhagen, Danmark, 2100
- The Danish HIV Cohort Study, Rigshospitalet
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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
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
One cohort of HIV patients with virological failure initiating Raltegravir One control cohort of HIV patients initiating HAART for the first time.
Beskrivelse
Inclusion Criteria:
Raltegravir cohort patients: From the Danish HIV Cohort Study (DHCS) we included all HIV-1 positive patients, who
- started raltegravir after 1 January 2006 and before 1 July 2009,
- had been treated with HAART previously
- had at least two VL tests done prior to initiation of raltegravir treatment,
- had virological failure prior to start of raltegravir and
- did not participate in randomized clinical trials on raltegravir. Virological failure was defined as VL > 500 copies/ml in the two latest VL tests prior to raltegravir initiation while on HAART treatment.
- Control cohort patients: From DHCS we identified a control cohort of HIV infected patients who started HAART for the first time after 1 January 2006 and before 1 July 2009. From this population we extracted two control patients for each raltegravir patient, each matched by gender, race (Caucasian, Black and other), route of HIV infection (homosexual, heterosexual, injection drug user (IDU) and other) and age (intervals of < 20 years, 20 to 30 years, 30 to 40 years, > 50 years).
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 |
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Raltegravir patients
HIV patients who initiated raltegravir due to virological failure
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Haart naive patients
HIV patients initiating HAART for the first time
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
virological suppression and CD4 cell gain
Tidsramme: 3,5 years
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3,5 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to first change of initial regimen.
Tidsramme: 3,5 years
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3,5 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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. januar 2006
Primær fullføring (Faktiske)
1. juli 2009
Studiet fullført (Faktiske)
1. desember 2009
Datoer for studieregistrering
Først innsendt
2. februar 2010
Først innsendt som oppfylte QC-kriteriene
2. februar 2010
Først lagt ut (Anslag)
3. februar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. februar 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. februar 2010
Sist bekreftet
1. januar 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 37593
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