- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00001057
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3
To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.
Studietype
Registrering
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Univ of Minnesota
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Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Med Clinic
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Saint Paul, Minnesota, Forente stater, 55101
- St Paul Ramsey Med Ctr
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Nebraska
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Omaha, Nebraska, Forente stater, 681985130
- Univ of Nebraska Med Ctr
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve Univ
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 191075098
- Thomas Jefferson Univ Hosp
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Texas
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Galveston, Texas, Forente stater, 775550435
- Univ of Texas Galveston
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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
Concurrent Medication:
Allowed:
- Antibiotics for bacterial infections as clinically indicated.
- Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
- Antipyretics.
- Analgesics.
- Allergy medications.
- Oral contraceptives.
- Nonprescription medications such as vitamins or herbal therapies.
Concurrent Treatment:
Allowed:
- Radiation therapy to local lesion only.
- Acupuncture.
Patients must have:
- HIV seropositivity.
- CD4 count >= 550 cells/mm3.
- No ARC or AIDS conditions by CDC criteria.
- Consent of parent or guardian if less than 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Presence of factors predisposing to pancreatitis such as active alcoholism.
- Other medical conditions that would interfere with study compliance.
Concurrent Medication:
Excluded:
- Other antiretrovirals or systemic immunomodulators.
- Systemic corticosteroids.
- Systemic cytotoxic chemotherapy.
- Intravenous pentamidine.
Concurrent Treatment:
Excluded:
- Radiation therapy except to local lesion.
Patients with the following prior conditions are excluded:
- History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
- History of grade 2 or worse peripheral neuropathy.
- History of pancreatitis.
- Bacterial infection requiring antibiotics within 14 days prior to study entry.
Prior Medication:
Excluded:
- Prior HIV therapy with antiretrovirals or systemic immunomodulators.
Prior Treatment:
Excluded within 2 weeks prior to study entry:
- Transfusion.
Active substance abuse or alcoholism.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Carey J
- Studiestol: Erice A
- Studiestol: Balfour H
- Studiestol: Henry K
- Studiestol: Hasse A
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
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Infeksjoner
- Ervervet immunsviktsyndrom
- 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 275
- 11251 (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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