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A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

23. juni 2005 opdateret af: Glaxo Wellcome

An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients

To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektioner

Intervention / Behandling

Medicin: Abacavirsulfat

Detaljeret beskrivelse

Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.

The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.

Undersøgelsestype

Interventionel

Tilmelding

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- California
  - Greenbrae, California, Forenede Stater, 94904
    - Marin County Specialty Clinic
  - Los Angeles, California, Forenede Stater, 90036
    - Kraus Med Partners
  - San Francisco, California, Forenede Stater, 94109
    - ViRx Inc
- Florida
  - Altamonte Springs, Florida, Forenede Stater, 32701
    - IDC Research Initiative
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - North Broward Hosp District
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30308
    - AIDS Research Consortium of Atlanta
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536
    - Univ of Kentucky Med Ctr
- New York
  - New York, New York, Forenede Stater, 10003
    - Beth Israel Med Ctr

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

Inclusion Criteria

Patients must have:

CD4+ cell count >= 100 /mm3.
Plasma HIV RNA >= 30,000 copies/ml.
Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
Parent or legal guardian to sign written, informed consent for patients under the age of 18.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.

Concurrent Medication:

Excluded:

Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
Patients receiving other investigational drugs.
Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
Treatment with immunomodulators.
Patients on methadone.

Concurrent Treatment:

Excluded:

Treatment with radiation therapy within the 24 weeks of the study. NOTE:
Localized radiation therapy may be permitted following consultation with the sponsor.

Patients with any of the following prior conditions are excluded:

Subjects with a history of lymphoma.
Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.
Investigational HIV vaccine within the past 3 months.
Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.

Prior Treatment:

Excluded:

Treatment with radiation therapy within 1 month of entry.

Risk Behavior:

Excluded:

Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.

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

Glaxo Wellcome

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 1997

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

238C
CNAA 2003

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 .