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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering

180

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

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

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

1 dag til 3 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Dobbelt

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)

Etterforskere

  • Studiestol: A Kovacs
  • Studiestol: R Husson

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

  • 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

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

Studiet fullført (Faktiske)

1. juni 1998

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 (Faktiske)

1. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACTG 239
  • 11216 (DAIDS ES Registry Number)

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. .

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