- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00000823
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration.
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks.
PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Studietype
Registrering
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Univ of Alabama at Birmingham
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California
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San Francisco, California, Forente stater, 941102859
- San Francisco Gen Hosp
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Colorado
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Denver, Colorado, Forente stater, 80262
- Univ of Colorado Health Sciences Ctr
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Florida
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Miami, Florida, Forente stater, 331361013
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Forente stater, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp
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Chicago, Illinois, Forente stater, 60640
- Louis A Weiss Memorial Hosp
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Chicago, Illinois, Forente stater, 606575147
- Illinois Masonic Med Ctr
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Indiana
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Indianapolis, Indiana, Forente stater, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, Forente stater, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hosp
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New York
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Bronx, New York, Forente stater, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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New York, New York, Forente stater, 10003
- Beth Israel Med Ctr
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New York, New York, Forente stater, 10016
- Bellevue Hosp / New York Univ Med Ctr
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Rochester, New York, Forente stater, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 275997215
- Univ of North Carolina
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Ohio
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Cincinnati, Ohio, Forente stater, 452670405
- Univ of Cincinnati
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Columbus, Ohio, Forente stater, 432101228
- Ohio State Univ Hosp Clinic
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Washington
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Seattle, Washington, Forente stater, 981224304
- Univ of Washington
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
Patients must have:
- HIV-1 seropositivity.
- CD4 count >= 550 cells/mm3.
- Asymptomatic disease.
- No prior antiretroviral therapy.
- Consent of parent or guardian if less than 18 years old.
PER AMENDMENT 6/18/96:
- Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Medical condition that precludes study compliance.
Concurrent Medication:
Excluded:
- Antiretrovirals other than study drugs.
- Biologic response modifiers including erythropoietin and G-CSF.
- Systemic corticosteroids.
- Systemic cytotoxic chemotherapy.
- Intravenous pentamidine.
Concurrent Treatment:
Excluded:
- Systemic radiation therapy.
Patients with the following prior conditions are excluded:
- History of grade 2 or worse peripheral neuropathy.
- History of pancreatitis or factors predisposing to pancreatitis.
Prior Medication:
Excluded:
- Prior antiretrovirals.
- Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry.
Chronic alcoholism.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Johnson V
- Studiestol: Collier AC
Studierekorddatoer
Studer hoveddatoer
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdomsattributter
- Infeksjoner
- Smittsomme sykdommer
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Antimetabolitter
- Zidovudin
- Didanosin
Andre studie-ID-numre
- ACTG 276
- 11252 (Registeridentifikator: 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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