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Induction-maintenance of Lopinavir/r in HIV-infected Subjects

4. september 2015 opdateret af: Pedro Cahn, Fundación Huésped

Study ACA-ARGE-04-001 "A Pilot, Open-Label Study Assessing Safety, Tolerability, Efficacy of a Simplified Lopinavir/Ritonavir Induction/Maintenance Therapy in HIV-Infected Subjects on Their First Protease Inhibitor-Based Regimen".

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1202ABB
        • Fundación Huésped
      • Buenos Aires,, Argentina, 1141
        • Helios Salud
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
  • Mexico
      • Mexico DF, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the IRB / IEC approved informed consent form.
  • Subject is HIV positive and on their first antiretroviral treatment regimen, based on any two NRTIs plus lopinavir/ritonavir or a ritonavir-boosted PI combination. Subject must have had no previous exposure to other regimens.
  • Subject has a viral load <50 copies/ml at the time of baseline evaluation for at least 6 months.
  • Subject has a CD4 cell count ³ 100 cells/mm3.
  • Subject is aged >18 years.
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject has not been treated for an active opportunistic infection within 30 days of screening.
  • If female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
  • Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. The subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

  • Subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol.
  • Subject has a viral load of > 50 copies/ml
  • Subject is HBsAg +
  • Subject has active tuberculosis or an opportunistic infection.
  • Subject has active malignancy (except Kaposi's Sarcoma).
  • Subject has liver failure as evidenced by ALT / AST > 5 x Upper Limit of Normal (ULN).
  • Female subject is pregnant or lactating.
  • Subject has received an investigational drug within 30 days prior to the initiation of the study.
  • Subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lopinavir/ritonavir monotherapy
Patients with undetectable viral load while on 1st line ARV therapy will be randomized to the expermental arm: Lopinavir/ritonavir monotherapy
Medicin: Lopinavir/ritonavir simplification strategy
Simplification
Andre navne:
  • Kaletra monotherapy simplification strategy
Aktiv komparator: Lopinavir/Ritonavir plus 2 NRTIs
Patients randomized to this arm will continue with standard of care triple therapy, based on Lopinavir/Ritonavir plus 2 NRTIs
Medicin: Lopinavir/ritonavir simplification strategy
Simplification
Andre navne:
  • Kaletra monotherapy simplification strategy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks
Tidsramme: 48 weeks
48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación Huésped

Samarbejdspartnere

Abbott

Efterforskere

  • Studiestol: Pedro E Cahn, MD, PhD, Fundacion Huesped, Buenos Aires, Argentina
  • Ledende efterforsker: Isabel L Cassetti, MD, Helios Salud, Buenos Aires, Argentina
  • Ledende efterforsker: Juan Sierra Madero, MD, Instituto Nacional de Ciencias Medicas y Nutricio Salvador Zurbaran, Mexico

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2005

Primær færdiggørelse (Faktiske)

1. december 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

7. september 2005

Først indsendt, der opfyldte QC-kriterier

7. september 2005

Først opslået (Skøn)

12. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACA-ARGE-04-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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