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BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (BATAR)

18. juli 2017 oppdatert av: Community Research Initiative of New England

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

43

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Spectrum Medical Group
    • California
      • Los Angeles, California, Forente stater, 90028
        • AIDS Healthcare Foundation
    • Colorado
      • Denver, Colorado, Forente stater, 80204
        • Denver public Health
    • District of Columbia
      • Washington, D.C., District of Columbia, Forente stater, 20009
        • Whitman-Walker Clinic
    • Florida
      • Orlando, Florida, Forente stater, 32803
        • Orlando Immunology Center
      • Vero Beach, Florida, Forente stater, 32960
        • Treasure Coast Infectious Disease Consultants
    • Kansas
      • Wichita, Kansas, Forente stater, 67214
        • Christi Research
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Community Research Initiative of New England - Boston
    • Texas
      • Dallas, Texas, Forente stater, 75804
        • David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • HIV-1 infection
  • Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
  • No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
  • Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
  • CD4 count>200
  • No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
  • Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
  • Ability and willingness to provide written informed consent and comply with protocol requirements

Exclusion Criteria:

  • Prior exposure to raltegravir or elvitegravir
  • Women who are pregnant, breast-feeding, or with a positive pregnancy test
  • Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
  • Life expectancy less than 6 months
  • Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
  • Treatment with proton-pump inhibitor or H2-receptor antagonist
  • ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
  • Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
  • Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

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)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention Arm No.1
Legemiddel: atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Legemiddel: atazanavir/raltegravir
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Eksperimentell: Intervention Arm No.2
Legemiddel: atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Legemiddel: atazanavir/raltegravir
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Aktiv komparator: Control Arm
Continue baseline regimen
Legemiddel: atazanavir/tenofovir/emtricitabine
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Andre navn:
  • Truvada

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maintenance of Virologic Suppression
Tidsramme: 48 weeks
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
48 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Difference in CD4 From Baseline to Week 48
Tidsramme: Baseline and Week 48
Change in mean CD4 from Baseline to Week 48.
Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Tidsramme: Baseline and Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Tidsramme: baseline and 48 weeks
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
baseline and 48 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Community Research Initiative of New England

Samarbeidspartnere

Bristol-Myers Squibb
Merck Sharp & Dohme LLC

Etterforskere

  • Hovedetterforsker: Calvin J Cohen, MD, MSc, Community Research Initiative

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

Studiestart

1. desember 2009

Primær fullføring (Faktiske)

1. februar 2012

Studiet fullført (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

30. juni 2009

Først innsendt som oppfylte QC-kriteriene

1. juli 2009

Først lagt ut (Anslag)

2. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 09-102

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. .

Kliniske studier på HIV

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Forhold

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