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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

402

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiet fullført (Faktiske)

1. januar 2006

Datoer for studieregistrering

Først innsendt

10. mai 2002

Først innsendt som oppfylte QC-kriteriene

10. mai 2002

Først lagt ut (Anslag)

13. mai 2002

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A5073
  • 10073 (Registeridentifikator: DAIDS ES)
  • ACTG A5073
  • AACTG A5073

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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