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A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

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

A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation

Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

While many factors contribute to the success or failure of antiretroviral therapy for HIV, among the most important are factors that influence adherence to a treatment regimen, such as duration of therapy, dosing frequency, pill burden, side effects, and patient behaviors. Inconsistent adherence or nonadherence to antiretroviral therapy can result in suboptimal drug exposure. Suboptimal drug exposure can, in turn, impact short- and long-term patient outcomes by increasing the likelihood of drug resistant HIV mutants and subsequent virologic and clinical failure. It is therefore essential to design treatment regimens that promote long-term adherence to potent antiretroviral therapy. This study will evaluate the relative contribution of reduced-frequency dosing and directly observed therapy on the magnitude and durability of virologic suppression in patients treated with potent antiretroviral therapy.

Patients will be randomly assigned to one of three study arms. Arms A, B, and C receive the same daily dosage of lopinavir/ritonavir (LPV/r), emtricitabine (FTC), and stavudine extended release (d4T XR) or tenofovir DF (TDF). In Arm A, drugs are self-administered for 48 weeks; LPV/r is taken twice daily and FTC and d4T XR or TDF once daily. In Arm B, all drugs are self-administered once daily for 48 weeks. In Arm C, drugs are taken once a day under directly observed therapy during Weeks 0-24, and then by self-administration during Weeks 25-48. Adherence to the regimen is measured using an electronic drug monitoring system. Viral load, CD4 and CD8 T cell responses, population pharmacokinetics, and quality of life indicators are measured throughout the study. The tolerability and safety of the treatment regimens are also monitored.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

402

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
    • California
      • Los Angeles, California, Forenede Stater, 90033-1079
        • USC CRS
      • Sacramento, California, Forenede Stater
        • Univ. of California Davis Med. Ctr., ACTU
      • San Diego, California, Forenede Stater, 92103
        • Ucsd, Avrc Crs
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80262
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Univ. of Miami AIDS CRS
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816-2396
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Adult AIDS CRS
      • Baltimore, Maryland, Forenede Stater, 21201
        • IHV Baltimore Treatment CRS
    • Massachusetts
      • Fall River, Massachusetts, Forenede Stater
        • SSTAR, Family Healthcare Ctr.
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455-0392
        • University of Minnesota, ACTU
    • New York
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med. Ctr., ACTU
      • New York, New York, Forenede Stater, 10016
        • NY Univ. HIV/AIDS CRS
      • Rochester, New York, Forenede Stater, 14215
        • Univ. of Rochester ACTG CRS
      • Rochester, New York, Forenede Stater, 14642-0001
        • AIDS Care CRS
      • Rochester, New York, Forenede Stater, 14642-0001
        • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Unc Aids Crs
      • Greensboro, North Carolina, Forenede Stater, 27401-1004
        • Regional Center for Infectious Disease, Wendover Medical Center CRS
      • Raleigh, North Carolina, Forenede Stater
        • Wake County Health and Human Services CRS
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-0405
        • Univ. of Cincinnati CRS
      • Cleveland, Ohio, Forenede Stater, 44109-1998
        • MetroHealth CRS
      • Columbus, Ohio, Forenede Stater
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-2582
        • Pitt CRS
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • The Miriam Hosp. ACTG CRS
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Vanderbilt Therapeutics CRS
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington AIDS CRS
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • Puerto Rico-AIDS CRS
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika
        • Wits HIV 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

  • HIV infection
  • Age 13 years or older and have written consent of guardian if under 18
  • Weigh at least 88 pounds
  • Viral load of 2000 copies/ml or more within 90 days before study entry
  • Have not taken anti-HIV drugs for more than 7 days
  • Agree to use acceptable methods of contraception during the study and for 1 month after stopping the study drugs

Exclusion Criteria

  • Pregnant or breastfeeding
  • In jail
  • Sensitive or allergic to any part of the study drugs
  • Treated with acute systemic therapy for a serious infection or other serious medical illness within 7 days prior to study entry, unless the participant has completed 7 days of therapy and is clinically stable
  • Recent serious illness, including pancreatitis or peripheral neuropathy
  • Alcohol or illicit drug abuse
  • Taken any of the following within 14 days before study entry: investigational drugs, anti-HIV vaccines, drugs that may cause pancreatitis or peripheral neuropathy, or drugs that are associated with CYP3A
  • Treated for cancer (not including minimal Kaposi's sarcoma) within 30 days before study entry
  • History of mental illness that might interfere with the study

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
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

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: Donna Mildvan, MD, Beth Israel Medical Center
  • Studiestol: Charles Flexner, MD, Johns Hopkins University Hospital

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. januar 2006

Datoer for studieregistrering

Først indsendt

10. maj 2002

Først indsendt, der opfyldte QC-kriterier

10. maj 2002

Først opslået (Skøn)

13. maj 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5073
  • 10073 (Registry Identifier: DAIDS ES)
  • ACTG A5073
  • AACTG A5073

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 lopinavir/ritonavir

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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