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An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen

23. juni 2005 opdateret af: Glaxo Wellcome

To assess the safety, tolerance, and efficacy of amprenavir (APV) plus abacavir (ABC) in patients who have previously failed antiretroviral treatment containing a protease inhibitor (PI). To provide open-label, pre-approval access to APV for adults and adolescents with HIV-1 infection and limited treatment options.

This study is being conducted to provide open-label APV to patients in danger of HIV disease progression, as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in combatting HIV progression and may help those in need, prior to regulatory approval.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This study is being conducted to provide open-label APV to patients in danger of HIV disease progression, as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in combatting HIV progression and may help those in need, prior to regulatory approval.

Patients are stratified into one of the following treatment options:

Non-nucleoside reverse transcriptase inhibitor (NNRTI)-naive:

Option 1- APV / ABC / PI / NNRTI / +nucleoside reverse transcriptase inhibitor(s) (NRTI) Option 2- APV / ABC / NNRTI / NRTI(s)

NNRTI-Experienced Patients:

Option 1- APV / ABC / PI / +NRTI(s) Option 2- APV / ABC / +NRTI(s) To assess clinical efficacy, lab values (i.e., hematology, serum chemistry, plasma HIV-1 viral load determination and CD4+ cell count measurements) are collected at pre-entry and every 12 weeks thereafter.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • North Carolina
      • Research Triangle Park, North Carolina, Forenede Stater, 277093398
        • Glaxo Wellcome Inc

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

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatic failure with elevated ALT and AST values.
  • Malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or render the patient unable to take oral medication.
  • Renal failure requiring dialysis.

Concurrent Medication:

Excluded:

Patients currently participating in, or who would qualify for or have access to, an enrolling study of APV (ACTG 398 and ACTG 400).

Patients with the following prior conditions are excluded:

  • Patients suffering from serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which, in the opinion of the investigator, would compromise the safety of the patient.
  • History of clinically relevant pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

  • Previous treatment with more than one HIV protease inhibitor.
  • ABC use for greater than 8 weeks prior to enrollment into this study.

Risk Behavior:

Excluded:

Patients with current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the patient's ability to comply with the requirements of the study.

Patients have:

  • HIV-1 infection.
  • CD4+ cell count less than or equal to 400 cells/mm3 and plasma HIV-1 RNA greater than or equal to 10,000 copies/ml at the first pre-entry assessment.
  • Evidence of failure on an antiretroviral treatment regimen containing a protease inhibitor.
  • Clinical evidence of failure in their current regimen and require antiretroviral therapy, and need APV plus ABC to induce viral load suppression.

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

Samarbejdspartnere og efterforskere

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

Sponsor

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.

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. april 1999

Mere information

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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