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Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

23. juni 2005 opdateret af: Glaxo Wellcome
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

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

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90073
        • Wadsworth Veterans Administration Med Ctr
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco Veterans Administration Med Ctr
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20422
        • Veterans Administration Med Ctr
      • Washington, District of Columbia, Forenede Stater, 203075001
        • Walter Reed Army Med Ctr
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Dr Gordon Dickinson
    • New York
      • New York, New York, Forenede Stater, 10010
        • Dr Gigi Diamond / New York Veterans Administration
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Houston Veterans Administration 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with unstable disease characterized by the following are excluded:

  • Hospitalization within the past 14 days.
  • Major opportunistic infection, current or past.
  • An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as:
  • Temperature = or > 100.5 degrees F.
  • Night sweats.
  • Weight loss = or > 10 percent of body weight.
  • Diarrhea (3 or more bowel movements/day).
  • Persistent cough, shortness of breath, or dyspnea on exercise.
  • Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a) gradient.
  • Altered mental status, seizures, or focal neurologic signs.
  • Abnormal computerized tomography (CT) scan or magnetic resonance imaging (MRI) suggestive of toxoplasmosis, peripheral mononuclear leukocytes, lymphoma, or other focal abnormality of the central nervous system (CNS).
  • Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or other meningitis. (The decision to perform invasive tests, such as lumbar puncture, specialized microbiological tests such as bone marrow culture for Mycobacteria or Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI should be based on clinical assessment of the patient.)
  • Kaposi's sarcoma.
  • Lymphoma; malignancy requiring chemotherapy.
  • Dementia.
  • Requiring hemodialysis or renal insufficiency or failure.
  • Leukopenia.
  • Thrombocytopenia.

Patients with the following are excluded:

  • Unstable disease.
  • Kaposi's sarcoma.
  • Lymphoma; malignancy requiring chemotherapy.
  • Dementia.
  • Major opportunistic infection, current or past.
  • Anemia (hemoglobin less than 9.5 g/dl).

Prior Medication:

Excluded within 1 month of study entry:

  • Ribavirin or zidovudine (AZT) or other antivirals.
  • Immunomodulating agents.

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. januar 1990

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 016a
  • VA Study 298

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 .

Abonner