- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00002151
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
23. juni 2005 opdateret af: Hoechst Marion Roussel
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection.
To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
200
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 366880002
- Clinical Investigations Health Services
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California
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Beverly Hills, California, Forenede Stater, 90211
- California Clinical Trials Med Group
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Los Angeles, California, Forenede Stater, 90027
- Southwest Community Based AIDS Treatment Group - COMBAT
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San Francisco, California, Forenede Stater, 94110
- UCSF - San Francisco Gen Hosp
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20037
- George Washington Univ / Hershey Med Ctr
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Florida
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Coral Gables, Florida, Forenede Stater, 33146
- Community Research Initiative of South Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- North Broward Hosp District
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Independent Investigator
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Sarasota, Florida, Forenede Stater, 34239
- Clinical Research Ctr
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Vero Beach, Florida, Forenede Stater, 32960
- Independent Investigator
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Illinois
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Chicago, Illinois, Forenede Stater, 60657
- Ctr for Special Immunology
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Univ of Kansas School of Medicine
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- New Orleans Institute of Clinical Investigation
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Univ Health Ctr
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Missouri
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Kansas City, Missouri, Forenede Stater, 64132
- Antibiotic Research Associates
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New Jersey
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Newark, New Jersey, Forenede Stater, 071032842
- North Jersey Community Research Initiative
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New York
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Rochester, New York, Forenede Stater, 14620
- Community Health Network
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Stony Brook, New York, Forenede Stater, 117948153
- SUNY / Health Sciences Ctr at Stony Brook
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Ohio
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Toledo, Ohio, Forenede Stater, 43608
- Infectious Disease Associates
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Clinic
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Texas
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Dallas, Texas, Forenede Stater, 752359103
- Univ of Texas Southwestern Med Ctr of Dallas
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Galveston, Texas, Forenede Stater, 775550835
- Univ TX Galveston Med Branch
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Houston, Texas, Forenede Stater, 77006
- Houston Clinical Research Network
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prior antiretroviral agents for up to 6 months per agent.
Patients must have:
- HIV infection.
- Asymptomatic or mildly symptomatic.
- CD4 count 301 - 500 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Unable or unwilling to comply with study procedures.
Concurrent Medication:
Excluded:
- Chemoprophylactic therapy for mycobacterial infection.
- Any nonstudy prescription medications without approval of investigator.
Patients with the following prior conditions are excluded:
- History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
- History of intolerance to lactose.
- Chronic diarrhea within 6 months prior to study entry.
- Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
Prior Medication:
Excluded:
- Antiretroviral therapy within 2 weeks prior to study entry.
- Prior HIV vaccines.
- Biological response modifiers within 30 days prior to study entry.
- Prior foscarnet.
- Any investigational drug with a washout < 5 half-lives prior to study entry.
- Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.
Recent history of alcohol and/or drug abuse.
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
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.
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 (Skøn)
24. juni 2005
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2005
Sidst verificeret
1. marts 1996
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 221C
- 028574PR0004
- NDPR0004
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 .
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