Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Comparison of ddI Versus Zidovudine in HIV-Infected Patients

11. mars 2011 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering

1500

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

Bristol-Myers Squibb

Etterforskere

  • Studiestol: R Dolin

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

7. desember 2022

Primær fullføring (Faktiske)

1. oktober 1992

Studiet fullført

7. desember 2022

Datoer for studieregistrering

Først innsendt

2. november 1999

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. mars 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mars 2011

Sist bekreftet

1. januar 2003

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på HIV-infeksjoner

Kliniske studier på Zidovudin

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Ireland

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere