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Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

23. juni 2005 opdateret af: PPD

A Study of the Combination of Indinavir, Ritonavir, Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients: An Open-Label Study Investigating Differences Between Women and Men

The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.

Undersøgelsestype

Interventionel

Tilmelding

200

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Berkeley, California, Forenede Stater, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, Forenede Stater, 90033
        • Univ of Southern California
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Tampa, Florida, Forenede Stater, 33607
        • Saint Josephs Comprehensive Research Institute
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02210
        • JSI Research and Training Institute
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • Univ of Med & Dentistry of New Jersey
    • New York
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med Ctr
      • New York, New York, Forenede Stater, 10037
        • Harlem Hosp Ctr
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Med Ctr
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37212
        • Vanderbilt Univ School of Medicine
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • Univ of Texas Southwestern Med Ctr
  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Ponce Univ Hosp
      • Rio Piedras, Puerto Rico, 00935
        • Univ of Puerto Rico School of Med

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

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
  • Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
  • Failed to keep their viral load low during previous anti-HIV treatment.
  • Are at least 18 years of age.
  • Agree to use an effective barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have used a protease inhibitor for more than 14 days.
  • Have used ddI or d4T for more than 30 days.
  • Are pregnant or breast-feeding.
  • Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
  • Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
  • Are at risk for, or have had, pancreatitis (disease of the pancreas).
  • Have difficulty absorbing medications.
  • Have a cancer, other than Kaposi's sarcoma, that may require systemic treatment.
  • Have any medical condition or treatment that may cause a rise in viral load.
  • Have any other condition or previous treatment that would interfere with the study.
  • Are unable to take drugs by mouth.
  • Are receiving or have received recently any of the following drugs: terfenadine, astemizole, cisapride, triazolam, midazolam, ergot alkaloids, amiodarone, bepridil, flecainide, propafenone, quinidine, pimozide, rifampin, and intravenous (IV) pentamidine.
  • Are receiving vincristine, thalidomide, foscarnet, or cisplatin or other medications that may cause nerve damage.
  • Have received any experimental drug within 30 days prior to treatment.
  • Are receiving treatment with testosterone, anabolic steroids, growth hormone, or megestrol acetate, except for certain hormonal problems.

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: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PPD

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.

Studer store datoer

Studiestart

1. august 2000

Datoer for studieregistrering

Først indsendt

10. oktober 2000

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. juni 2001

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 312A
  • BMS 2000

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner