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Comparison of ddI Versus Zidovudine in HIV-Infected Patients

11. marts 2011 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection

To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts < 200 cells/mm3.

AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.

AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels.

It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.

Undersøgelsestype

Interventionel

Tilmelding

1500

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
      • Los Angeles, California, Forenede Stater, 900276016
        • Children's Hosp of Los Angeles/UCLA Med Ctr
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County - USC Med Ctr
      • Palo Alto, California, Forenede Stater, 94304
        • Palo Alto Veterans Adm Med Ctr / Stanford Univ
      • San Diego, California, Forenede Stater, 921036325
        • Univ of California / San Diego Treatment Ctr
      • Stanford, California, Forenede Stater, 94305
        • Stanford Univ School of Medicine
      • Sylmar, California, Forenede Stater, 91342
        • Olive View Med Ctr
      • Sylmar, California, Forenede Stater, 91342
        • Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
      • Torrance, California, Forenede Stater, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • Univ of Colorado Health Sciences Ctr
      • Denver, Colorado, Forenede Stater, 80262
        • Mountain States Regional Hemophilia Ctr / Univ of Colorado
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, Forenede Stater, 20009
        • Whitman - Walker Clinic
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • G E Morey Jr
      • Miami, Florida, Forenede Stater, 331361013
        • Univ of Miami School of Medicine
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hosp
      • Hines, Illinois, Forenede Stater, 60141
        • Edward Hines Veterans Administration Hosp
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 462025250
        • Indiana Univ Hosp
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Univ of Kansas School of Medicine
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana Comprehensive Hemophilia Care Ctr
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana State Univ Med Ctr / Tulane Med School
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Univ School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Charity Hosp / Tulane Univ Med School
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Harvard (Massachusetts Gen Hosp)
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Med Ctr
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess - West Campus
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Med Ctr
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Forenede Stater, 01605
        • Med Ctr of Central Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Univ of Massachusetts Med Ctr
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Univ of Minnesota
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68105
        • Nebraska Regional Hemophilia Ctr
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • Bronx, New York, Forenede Stater, 10465
        • Jack Weiler Hosp / Bronx Municipal Hosp
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Med Ctr / Bronx Municipal Hosp
      • Bronx, New York, Forenede Stater, 10468
        • Bronx Veterans Administration / Mount Sinai Hosp
      • Buffalo, New York, Forenede Stater, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Elmhurst, New York, Forenede Stater, 11373
        • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
      • New York, New York, Forenede Stater, 10021
        • Cornell Univ Med Ctr
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med Ctr / Peter Krueger Clinic
      • New York, New York, Forenede Stater, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Forenede Stater, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, Forenede Stater, 10025
        • Saint Luke's - Roosevelt Hosp Ctr
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Med Ctr
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Medical Center
      • Stony Brook, New York, Forenede Stater, 117948153
        • SUNY - Stony Brook
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY / State Univ of New York
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 275997215
        • Univ of North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ Med Ctr
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Bowman Gray School of Medicine / Wake Forest Univ
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 452670405
        • Holmes Hosp / Univ of Cincinnati Med Ctr
      • Columbus, Ohio, Forenede Stater, 432101228
        • Ohio State Univ Hosp Clinic
      • Toledo, Ohio, Forenede Stater, 43699
        • Med College of Ohio
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 170330850
        • Milton S Hershey Med Ctr
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Univ of Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
        • Hemophilia Ctr of Western PA / Univ of Pittsburgh
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Univ of Pittsburgh Med School
    • South Carolina
      • West Columbia, South Carolina, Forenede Stater, 29169
        • Julio Arroyo
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
    • Texas
      • Galveston, Texas, Forenede Stater, 77550
        • Univ TX Galveston Med Branch
      • Houston, Texas, Forenede Stater, 77030
        • Hermann Hosp / Univ Texas Health Science Ctr
      • Houston, Texas, Forenede Stater, 77030
        • Texas Children's Hosp / Baylor Univ
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Univ of Utah School of Medicine
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Dr Stephen L Green
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Univ of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Dr Brian Buggy
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Milwaukee County Med Complex
      • Milwaukee, Wisconsin, Forenede Stater, 53233
        • Great Lakes Hemophilia Foundation
  • Puerto Rico
      • San Juan, Puerto Rico, 009275800
        • San Juan 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

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

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Concurrent Medication:

Required:

  • Aerosolized pentamidine (300 mg every 4 weeks using a Respirgard II nebulizer). In the event of physiological intolerance, alternative prophylaxis may be: Trimethoprim / sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg/day.

Allowed:

Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT).

Treatment of opportunistic infections with other than sulfonamide containing drugs:

  • Pyrimethamine and sulfadiazine or clindamycin for suppression of toxoplasmosis acquired after study entry; fluconazole or amphotericin B for suppression of cryptococcosis or ketoconazole for candidiasis.

Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities.

Isoniazid (INH) if no other acceptable therapy is available.

Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note:

  • Ketoconazole and dapsone should be taken 2 hours before or 2 hours after taking ddI (amendment 5/20/91).

Concurrent Treatment:

Allowed:

  • Blood transfusions for hemoglobin toxicity.

Patients must:

  • Have a diagnosis of AIDS or advanced AIDS related complex (ARC), or per 8/09/90 amendment, asymptomatic HIV infection with CD4 count = or < 200 cells/mm3.
  • Be either naive to zidovudine (AZT) or have taken AZT for = or < 48 weeks.
  • Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. For patients with 2 months or less experience with AZT, PCP infection will be the single and only AIDS-defining infection and must have been within 120 days of study entry. Per amendment, other AIDS-defining conditions are allowed in the 8 weeks prior to study entry (for patients in the AZT stratum).Only one episode of PCP is permitted unless patient has > 2 months AZT experience in which case > 1 prior episode of PCP infection is allowed.
  • Not have experienced a major intolerance to AZT at doses of at least 500 mg if the patient was on AZT therapy for = or < 48 weeks. A major intolerance is defined as recurrent grade 3 or greater toxicity which results in discontinuation of drug.

Allowed:

  • Basal cell carcinoma.
  • In situ carcinoma of the cervix.
  • Occasional premature atrial or ventricular contraction.
  • Patients developing new opportunistic infections after study entry will remain on this protocol.
  • Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3.

Prior Medication:

Allowed:

  • Previous treatment with zidovudine (AZT) up to 48 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or diseases are excluded:

  • Kaposi's sarcoma (KS) with evidence of visceral disease or where KS requires chemotherapy; subjects with localized KS having CD4 counts = or > 200 cells/mm3.
  • AIDS-dementia complex = or > stage 2.
  • Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.
  • Intractable diarrhea.
  • History of seizures within past 6 months or currently requiring anticonvulsants for control.
  • History of past or current heart disease.
  • Presence of a malignancy likely in the investigators opinion to require cytotoxic myelosuppressive chemotherapy during the expected course of this trial.

Concurrent Medication:

Excluded:

  • Oral acidifying agents.
  • Neurotoxic drugs. NOTE: If patients require therapy for PCP with IV pentamidine, study mediation is stopped.

Patients with the following are excluded:

  • Active AIDS defining events. Maintenance therapy for prior AIDS-defining opportunistic infections is permitted.
  • Intolerance to AZT at doses of 500 mg because of recurrent grade 3 toxicity or greater which resulted in discontinuation of drug.
  • Neoplasms not specifically allowed.
  • Previous enrollment in any study of ddI, ddC or d4T.
  • > 48 weeks of AZT therapy.
  • An opportunistic infection not adequately controlled with suppressive therapies allowed in the protocol.
  • Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance study therapy.
  • Life expectancy = or < 6 months.

Prior Medication:

Excluded:

  • Ganciclovir.
  • AZT for = or > 48 weeks.

Excluded within 14 days of study entry:

  • Erythropoietin (Eprex).

Excluded within 30 days of study entry:

  • Anti-HIV therapy other than AZT.
  • Biologic response modifiers.
  • Other investigational drugs.
  • Corticosteroids.
  • Neurotoxic drugs.

Excluded within 90 days of study entry:

  • Ribavirin.

Prior Treatment:

Excluded within 14 days of study entry:

  • Transfusion.

Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

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

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

  • Studiestol: R Dolin

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

7. december 2022

Primær færdiggørelse (Faktiske)

1. oktober 1992

Studieafslutning

7. december 2022

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)

14. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2011

Sidst verificeret

1. januar 2003

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG 116
  • 070V1
  • ACTG 116-A
  • ACTG 116-B/117
  • AI454-008

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Zidovudin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner