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Evolution of L74V or K65R Mutations in VIremic Subjects on Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) (EVITA)

20 maggio 2008 aggiornato da: Orlando Immunology Center

Evolution of L74V or K65R Mutations in VIremic Subjects on TDF or ABC (EVITA)

This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confirmed first-time incomplete virologic suppression during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.

Subjects will have a screening genotype to establish adherence to their non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized.

Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the RT resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confirmed first-time incomplete virologic suppression during treatment with an initial ARV regimen consisting of at least 12 weeks of TDF or ABC + FTC or 3TC + NNRTI or PI. Subjects will be followed until substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.

Subjects will have screening genotype to establish adherence to their non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized.

Twenty subjects (maximum 10 per arm) will be enrolled at 10-20 U.S. sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A vs. Arm B will be a goal.

Inclusion Criteria

  1. Confirmed first-time incomplete virologic suppression during treatment with at least 12 weeks of an ARV regimen consisting of TDF or ABC + FTC or 3TC + NNRTI or PI (TDF as Truvada or individually with FTC, and ABC as Epzicom or individually with 3TC). Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.
  2. Screening HIV-1 RNA < 20,000 copies/mL obtained within 30 days prior to study entry.
  3. Screening CD4 cell count ≥ 200 cells/mL.
  4. Screening HIV-1 genotype with M184V or at least one treatment-related primary mutation.

  5. Routine labs as demonstrated by last available lab panel to be:

    • Hemoglobin > 8.0 g/dL;
    • Platelet count > 50,000/mm3;
    • AST (SGOT) < 210 U/L;
    • ALT (SGPT) < 240 U/L;
    • Alkaline phosphatase < 625 U/L;
    • Total bilirubin < 3.25 mg/dL; and
    • Calculated creatinine clearance ≥ 50 as estimated by the Cockcroft-Gault equation.
  6. If participating in sexual activity that could lead to pregnancy, female study subjects must use two forms of contraception, one of which must be a barrier method.
  7. Men and women aged ≥ 18 years.
  8. Ability and willingness of subjects to give written informed consent.

Exclusion Criteria

  1. Subjects with screening HIV-1 genotype that is wild-type or contains the resistance mutations K65R/x or L74V/x.
  2. Prior or current treatment with ARV regimen consisting of only nucleoside reverse transcriptase inhibitors (NRTIs), zidovudine (ZDV) or stavudine (d4T), more than 2 NRTIs, ritonavir-boosted or dual PI regimen.
  3. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. For non-serious illnesses, treatment of less than 21 days with larger doses of corticosteroids is permitted.
  4. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  5. Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restrictions.
  6. Unable to discontinue contraindicated current medications.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

20

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Fresno, California, Stati Uniti, 93702
        • Special Services Adult HIV Clinic
      • Los Angelos, California, Stati Uniti, 90022
        • AltaMed Health Services Corporation
      • Tarzana, California, Stati Uniti, 91356
        • Tarzana Treatment Center
      • Tarzana, California, Stati Uniti, 91356
        • Shared Medical Research Foundation
    • Florida
      • Orlando, Florida, Stati Uniti, 32803
        • Orlando Immunology Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60657
        • Northstar Medical Center
    • Michigan
      • Berkley, Michigan, Stati Uniti, 48072
        • Paul Benson, DO, PC
    • New York
      • New York, New York, Stati Uniti, 10011
        • Ricky Hsu, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19140
        • Temple University School of Medicine, Section of Infectious Diseases
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29605
        • Greenville Hospital System Infectious Disease Associates
    • Texas
      • Dallas, Texas, Stati Uniti, 75204
        • Nicholas C. Bellos, MD PA and Associates

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Confirmed first-time incomplete virologic suppression during treatment with at least 12 weeks of an ARV regimen consisting of TDF or ABC + FTC or 3TC + NNRTI or PI (TDF as Truvada or individually with FTC, and ABC as Epzicom or individually with 3TC). Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.
  2. Screening HIV-1 RNA < 20,000 copies/mL obtained within 30 days prior to study entry.
  3. Screening CD4 cell count ≥ 200 cells/mL.
  4. Screening HIV-1 genotype with M184V or at least one treatment-related primary mutation.

  5. Routine labs as demonstrated by last available lab panel to be:

    • Hemoglobin > 8.0 g/dL;
    • Platelet count > 50,000/mm3;
    • AST (SGOT) < 210 U/L;
    • ALT (SGPT) < 240 U/L;
    • Alkaline phosphatase < 625 U/L;
    • Total bilirubin < 3.25 mg/dL; and
    • Calculated creatinine clearance ≥ 50 as estimated by the Cockcroft-Gault equation.
  6. If participating in sexual activity that could lead to pregnancy, female study subjects must use two forms of contraception, one of which must be a barrier method.
  7. Men and women aged ≥ 18 years.
  8. Ability and willingness of subjects to give written informed consent.

Exclusion Criteria:

  1. Subjects with screening HIV-1 genotype that is wild-type or contains the resistance mutations K65R/x or L74V/x.
  2. Prior or current treatment with ARV regimen consisting of only NRTIs, ZDV or d4T, more than 2 NRTIs, ritonavir-boosted or dual PI regimen.
  3. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. For non-serious illnesses, treatment of less than 21 days with larger doses of corticosteroids is permitted.
  4. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  5. Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restrictions.
  6. Unable to discontinue contraindicated current medications.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Orlando Immunology Center

Collaboratori

GlaxoSmithKline

Investigatori

  • Direttore dello studio: Edwin DeJesus, MD, FACP, OIC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2006

Completamento primario (Effettivo)

1 maggio 2008

Completamento dello studio (Effettivo)

1 maggio 2008

Date di iscrizione allo studio

Primo inviato

5 aprile 2006

Primo inviato che soddisfa i criteri di controllo qualità

5 aprile 2006

Primo Inserito (Stima)

7 aprile 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 maggio 2008

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2008

Ultimo verificato

1 maggio 2008

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COL105034 (EVITA)
  • EVITA

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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