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A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

27. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma

This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T).

Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Previous ACTG studies show that discontinuation of one or two of a three-drug regimen (IDV, ZDV, 3TC) leads to prompt loss of viral suppression in the plasma. In this trial, it will be determined whether adding hydroxyurea (HU) to a suppressive regimen increases long term viral suppression. Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression.

Patients are equally randomized to one of three arms and receive treatment as follows:Arm A: IDV plus ddI plus d4T plus HU placebo. Arm B: IDV plus ddI plus d4T plus HU. Arm C: IDV plus 3TC/ZDV (or d4T plus 3TC). Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts.

Undersøgelsestype

Interventionel

Tilmelding

399

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Alabama Therapeutics CRS
    • California
      • Palo Alto, California, Forenede Stater, 943055107
        • Stanford CRS
      • San Diego, California, Forenede Stater, 921036325
        • Ucsd, Avrc Crs
      • San Mateo, California, Forenede Stater, 943055107
        • San Mateo County AIDS Program
      • Torrance, California, Forenede Stater, 90502
        • Harbor-UCLA Med. Ctr. CRS
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80262
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, Forenede Stater, 331361013
        • Univ. of Miami AIDS CRS
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University CRS
      • Chicago, Illinois, Forenede Stater, 60640
        • Weiss Memorial Hosp.
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
      • Indianapolis, Indiana, Forenede Stater, 462025250
        • Indiana Univ. School of Medicine, Wishard Memorial
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Univ. of Iowa Healthcare, Div. of Infectious Diseases
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Hemophilia Treatment Ctr.
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
        • Washington U CRS
      • Saint Louis, Missouri, Forenede Stater, 63112
        • St. Louis ConnectCare, Infectious Diseases Clinic
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 681985130
        • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    • New York
      • New York, New York, Forenede Stater, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • New York, New York, Forenede Stater
        • Beth Israel Med. Ctr., ACTU
      • Rochester, New York, Forenede Stater, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 275997215
        • Unc Aids Crs
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas HealthCare System, Carolinas Med. Ctr.
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Regional Center for Infectious Disease, Wendover Medical Center CRS
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 452670405
        • Univ. of Cincinnati CRS
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case CRS
      • Cleveland, Ohio, Forenede Stater, 441091998
        • MetroHealth CRS
      • Columbus, Ohio, Forenede Stater, 432101228
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington AIDS CRS

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

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

You may be eligible for this study if you:

  • Are 13 years or older.
  • Have documented HIV-1 infection.
  • Are currently receiving combined IDV, ZDV(or D4T), and 3TC for at least 6 consecutive months, resulting in HIV RNA less than 200 copies/ml and CD4 cell count greater than 200 cells/mm3.
  • Had a CD4 count greater than 100 cells/mm3 before starting current anti-HIV therapy.
  • Are of childbearing age and agree to practice abstinence or use of combined barrier and hormonal methods of birth control during and for 3 months after the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have taken various medications and have various laboratory results (see technical abstract).
  • Have cancer requiring chemotherapy.
  • Have an unexplained fever for 7 days or diarrhea for 15 days in the month before the start of the study.
  • Had prior peripheral neuropathy or hepatitis.
  • Recently underwent radiation, experimental, or infection therapy.
  • Are pregnant or breastfeeding.

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
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Collier A
  • Studiestol: Havlir D; Richman D
  • Studiestol: Tebas P

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

Studieafslutning (Faktiske)

1. august 2004

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 (Faktiske)

29. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5025
  • 10873 (Registry Identifier: DAIDS ES)
  • ACTG A5025

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 .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Indinavirsulfat

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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