Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Switching Undetectables to Selzentry (SUDS)

18 november 2014 bijgewerkt door: St. Hope Foundation

A Study in HIV+ Patients With CCR5-tropic Virus and Undetectable Viral Load on a First, Non-Selzentry®-Containing Regimen, Switching Them to Once-daily Selzentry® (600mg qd) Plus the Same 2 NRTIs Previously Administered

This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30) HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] and switch them to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The objective of the study is to determine if regimen tolerability/toxicity can be maintained or improved while maintaining virologic suppression following a switch to once-daily Selzentry®.

The study duration is 48 weeks. Patients must have an HIV-1 RNA <100 copies/mL for ≥3 months on their first HIV treatment regimen. Prior regimen modifications for reasons other than virologic failure are acceptable if any previously achieved virologic suppression has been maintained. A Trofile® DNA will be used to document exclusive CCR5 tropism. Patients with history of dual/mixed or CXCR4-tropic HIV-1 are excluded from participation. Patients with prior exposure to Selzentry® are also excluded. Patients that qualify for participation will discontinue the PI, NNRTI, or Integrase inhibitor portion of their regimen and begin Selzentry® 600mg QD. Patients will continue the two (2) NRTIs from the previous treatment regimen.

The primary endpoints is: the percentage of HIV positive patients with undetectable viral load (HIV-1 RNA <100 copies/mL) at Week 24.

Secondary endpoints are: the safety and tolerability of once-daily Selzentry® through Weeks 24 and 48(as measured by clinical and laboratory adverse events and regimen satisfaction questionnaire), the percentage of HIV positive patients with undetectable viral load (HIV-1 RNA < 100 copies/mL) at Week 48, the change from baseline in CD4+ T-cell counts at Weeks 24 and 48, the change from baseline in inflammatory markers (C-reactive protein) at Weeks 24 and 48, and assessment of resistance-associated mutations or viral tropism changes from baseline, if any, emerging at virologic failure.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

31

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Bellaire, Texas, Verenigde Staten, 77401
        • St. Hope Foundation, Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 18 years of age or older
  • Are capable of understanding and have signed an informed consent
  • Have documented HIV-1 infection by confirmatory laboratory
  • Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
  • Are able and willing to comply with all protocol requirements and procedures
  • Have HIV-1 RNA <100 copies/mL and documented CCR5 tropic virus
  • Are receiving their first highly active antiretroviral regimen for at least 12 weeks before screening and are willing to continue that regimen until the baseline visit (previous regimen modifications for reasons other than virologic failure are acceptable if any previously achieved virologic suppression has been maintained)
  • Antiretroviral regimen is composed of one NNRTI, one PI (including boosted PIs), or one integrase inhibitor AND two (2) NRTIs

Exclusion Criteria:

  • Any history of virologic failure or resistance associated mutations on prior resistance testing
  • Any history of dual/mixed- or CXCR4-tropic HIV-1
  • Any history of an active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
  • Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
  • Any significant acute illness within 1 week before the initial administration of study drug
  • Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e. secondary prophylaxis for opportunistic infections) will be eligible for the study
  • HCV infection requiring treatment during the study period

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Maraviroc
Patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] are switched to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs previously administered.
Geneesmiddel: Maraviroc
HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] are switched to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs previously administered.
Andere namen:
  • Selzentry®
  • Celsentri®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of Once-Daily Selzentry® through Week 24
Tijdsspanne: At Week 24
Percentage of HIV positive patients with Undetectable Viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI
At Week 24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of once-daily Selzentry® through Week 48
Tijdsspanne: At Week 48
The percentage of HIV positive patients with undetectable viral load (HIV-1 RNA < 100 copies/mL) on once-daily Selzentry plus 2 NRTI at Week 48
At Week 48
The safety of once-daily Selzentry® through Weeks 24 and 48
Tijdsspanne: Through Weeks 24 and 48
The safety of once-daily Selzentry® plus 2 NRTI measured by the frequency and severity of drug-related adverse events (including laboratory abnormalities) through Weeks 24 and 48 of the study.
Through Weeks 24 and 48
The change from baseline in CD4+ T-cell counts
Tijdsspanne: at Weeks 24 and 48
A change from the baseline measurement in CD4+ T-cell counts at Weeks 24 and 48 of the study.
at Weeks 24 and 48
The change from baseline in inflammatory markers (C-reactive protein)
Tijdsspanne: at Weeks 24 and 48
The change from the baseline measurement in inflammatory markers (C-reactive protein) at Weeks 24 and 48 of the study.
at Weeks 24 and 48
Resistance-Associated Mutations or Tropism Changes from Baseline
Tijdsspanne: at Weeks 24 and 48
Assessment of any resistance-associated mutations or changes in viral tropism compared to baseline, if any, that emerge upon the occurrence of virologic failure.
at Weeks 24 and 48
Tolerability of Once-Daily Selzentry®
Tijdsspanne: Through Weeks 24 and 48
The tolerability of once-daily Selzentry® plus 2 NRTI as measured by patient responses to the treatment regimen satisfaction questionnaire, assessed at Weeks 24 and 48 of the study.
Through Weeks 24 and 48

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

St. Hope Foundation

Medewerkers

GlaxoSmithKline

Onderzoekers

  • Hoofdonderzoeker: Stanley T. Lewis, M.D., MPH, St. Hope Foundation, Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2013

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

12 februari 2013

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2013

Eerst geplaatst (Schatting)

31 mei 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

19 november 2014

Laatste update ingediend die voldeed aan QC-criteria

18 november 2014

Laatst geverifieerd

1 november 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SUDS_GSK117335

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren