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Comparison of ddI Versus Zidovudine in HIV-Infected Patients

11 marzo 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione

1500

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaboratori

Bristol-Myers Squibb

Investigatori

  • Cattedra di studio: R Dolin

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

7 dicembre 2022

Completamento primario (Effettivo)

1 ottobre 1992

Completamento dello studio

7 dicembre 2022

Date di iscrizione allo studio

Primo inviato

2 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2001

Primo Inserito (Stima)

31 agosto 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 marzo 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 marzo 2011

Ultimo verificato

1 gennaio 2003

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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