- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00001049
A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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San Juan, Porto Rico, 009367344
- San Juan City Hosp
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San Juan, Porto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
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California
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La Jolla, California, Stati Uniti, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Long Beach, California, Stati Uniti, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Stati Uniti, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, Stati Uniti, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Oakland, California, Stati Uniti, 946091809
- Children's Hosp of Oakland
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San Francisco, California, Stati Uniti, 94110
- San Francisco Gen Hosp
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San Francisco, California, Stati Uniti, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Colorado
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Denver, Colorado, Stati Uniti, 802181088
- Children's Hosp of Denver
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06032
- Univ of Connecticut / Farmington
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 200102916
- Children's Hosp of Washington DC
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Washington, District of Columbia, Stati Uniti, 20060
- Howard Univ Hosp
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Florida
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Fort Lauderdale, Florida, Stati Uniti, 33311
- North Broward Hosp District
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Jacksonville, Florida, Stati Uniti, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Stati Uniti, 33161
- Univ of Miami (Pediatric)
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Riviera Beach, Florida, Stati Uniti, 33404
- Palm Beach County Health Dept
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Cook County Hosp
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Chicago, Illinois, Stati Uniti, 606143394
- Chicago Children's Memorial Hosp
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Chicago, Illinois, Stati Uniti, 606371470
- Univ of Chicago Children's Hosp
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Chicago, Illinois, Stati Uniti, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 701122699
- Tulane Univ / Charity Hosp of New Orleans
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Stati Uniti, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Children's Hosp of Michigan
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New Jersey
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Newark, New Jersey, Stati Uniti, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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Newark, New Jersey, Stati Uniti, 07103
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
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Newark, New Jersey, Stati Uniti, 071072198
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
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New York
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Albany, New York, Stati Uniti, 12208
- Children's Hosp at Albany Med Ctr
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Bronx, New York, Stati Uniti, 10457
- Bronx Lebanon Hosp Ctr
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New Hyde Park, New York, Stati Uniti, 11040
- Schneider Children's Hosp
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New York, New York, Stati Uniti, 10029
- Metropolitan Hosp Ctr
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New York, New York, Stati Uniti, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, Stati Uniti, 10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
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New York, New York, Stati Uniti, 10037
- Harlem Hosp Ctr
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New York, New York, Stati Uniti, 10029
- Mount Sinai Med Ctr / Pediatrics
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Rochester, New York, Stati Uniti, 14642
- Univ of Rochester Medical Center
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Syracuse, New York, Stati Uniti, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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North Carolina
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Durham, North Carolina, Stati Uniti, 277103499
- Duke Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 191044318
- Children's Hosp of Philadelphia
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Philadelphia, Pennsylvania, Stati Uniti, 191341095
- Saint Christopher's Hosp for Children
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South Carolina
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Charleston, South Carolina, Stati Uniti, 294253312
- Med Univ of South Carolina
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Children's Hosp of the King's Daughters
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Richmond, Virginia, Stati Uniti, 23219
- Med College of Virginia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Doppio
Collaboratori e investigatori
Investigatori
- Cattedra di studio: A Kovacs
- Cattedra di studio: R Husson
Pubblicazioni e link utili
Pubblicazioni generali
- 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
Studiare le date dei record
Studia le date principali
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Malattie da virus lenti
- Infezioni da HIV
- Infezioni
- Sindrome da immunodeficienza acquisita
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori della trascrittasi inversa
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti anti-HIV
- Agenti antiretrovirali
- Antimetaboliti
- Zidovudina
- Didanosina
Altri numeri di identificazione dello studio
- ACTG 239
- 11216 (DAIDS ES Registry Number)
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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