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A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV

28. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection

To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants.

PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms.

Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.

In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended 6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI combination therapy. After pharmacokinetic data are obtained, an additional cohort of patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of age.) Part B patients less than 90 days of age (was less than 180 days of age; amended 6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients continue treatment until 12 months after the last patient on Part B is enrolled. PER AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm, randomized, double-blind study to assess safety, toxicity and tolerability as well as anti-HIV activity of ddI or AZT/ddI.

Undersøgelsestype

Interventionel

Tilmelding

180

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Univ of Alabama at Birmingham Schl of Med / Pediatrics
    • California
      • La Jolla, California, Forenede Stater, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, Forenede Stater, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, Forenede Stater, 905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Oakland, California, Forenede Stater, 946091809
        • Children's Hosp of Oakland
      • San Francisco, California, Forenede Stater, 94110
        • San Francisco Gen Hosp
      • San Francisco, California, Forenede Stater, 941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Colorado
      • Denver, Colorado, Forenede Stater, 802181088
        • Children's Hosp of Denver
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06032
        • Univ of Connecticut / Farmington
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 200102916
        • Children's Hosp of Washington DC
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District
      • Jacksonville, Florida, Forenede Stater, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, Forenede Stater, 33161
        • Univ of Miami (Pediatric)
      • Riviera Beach, Florida, Forenede Stater, 33404
        • Palm Beach County Health Dept
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hosp
      • Chicago, Illinois, Forenede Stater, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, Forenede Stater, 606371470
        • Univ of Chicago Children's Hosp
      • Chicago, Illinois, Forenede Stater, 60612
        • Univ of Illinois College of Medicine / Pediatrics
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 021155724
        • Children's Hosp of Boston
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Forenede Stater, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hosp of Michigan
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • Newark, New Jersey, Forenede Stater, 07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
      • Newark, New Jersey, Forenede Stater, 071072198
        • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Children's Hosp at Albany Med Ctr
      • Bronx, New York, Forenede Stater, 10457
        • Bronx Lebanon Hosp Ctr
      • New Hyde Park, New York, Forenede Stater, 11040
        • Schneider Children's Hosp
      • New York, New York, Forenede Stater, 10029
        • Metropolitan Hosp Ctr
      • New York, New York, Forenede Stater, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, Forenede Stater, 10032
        • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
      • New York, New York, Forenede Stater, 10037
        • Harlem Hosp Ctr
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Medical Center
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 277103499
        • Duke Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 191341095
        • Saint Christopher's Hosp for Children
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 294253312
        • Med Univ of South Carolina
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hosp of the King's Daughters
      • Richmond, Virginia, Forenede Stater, 23219
        • Med College of Virginia
  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS

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

1 dag til 3 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis.

Allowed:

  • Acetaminophen if not on a continual basis.

NOTE:

  • Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution.

Patients must have at least one of the following:

  • Documented HIV infection.
  • Been born to an HIV-infected woman and receiving AZT.

PER AMENDMENT 4/8/97:

  • Number 2 above no longer required with closure of Part A of study.
  • Patients must have signed, informed consent of parent or legal guardian.

PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age.

PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age.

NOTE:

  • All patients must have been more than 34 weeks gestation at birth.

Prior Medication:

Allowed:

  • Prior vaccine therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Pancreatitis.
  • Clinically unstable condition.
  • Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status.

Concurrent Medication:

Excluded:

  • Vaccine therapy.

Patients with the following prior condition are excluded:

  • Pancreatitis at any time since birth.

Prior Medication:

Excluded in Part B patients only:

  • More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.

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
  • Maskning: Dobbelt

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)

Efterforskere

  • Studiestol: A Kovacs
  • Studiestol: R Husson

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

  • McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

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

Studieafslutning (Faktiske)

1. juni 1998

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 (Faktiske)

1. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG 239
  • 11216 (DAIDS ES Registry Number)

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